Clinical Trials

The purpose of this study is to find out whether restoring blood flow to all blocked or narrowed arteries with a percutaneous coronary intervention (PCI, a procedure that opens the blockage or widens the narrowed artery with a stent) is better than using medications alone after a transcatheter aortic valve replacement (TAVR).

To qualify for the study you must have:

• Severe symptomatic aortic valve stenosis and qualify for TAVR procedure.
• Have a blocked or narrowed coronary artery with 70% or greater narrowing.

Once you have gone through the TAVR procedure, you will be randomized to opening the narrowed arteries or being treated with optimal medical therapy only. You will be followed at 1 month, 6 months and yearly for five years.

Study Team: Dr. Mansoor Qureshi. Nora Marchelletta RN, BSN

The study is evaluating the safety and effectiveness of a new therapy, INCLISIRAN, which lowers LDL-cholesterol (bad cholesterol) in patients who have recently had a heart attack. The study is looking at the changes in your LDL levels. INCLISIRAN, has been shown in previous studies to lower LDL-cholesterol by blocking the production of a protein call PCSK9. This protein reduces the liver’s natural ability to remove LDL-cholesterol form the blood.

To qualify for the study you must have:

• Been recently hospitalized with a heart condition.
• Currently taking a cholesterol lowering medication or have been told you are intolerant to statins.

If you decide to participate, it is very important that you continue to take your cholesterol lowering medication. One half of the participants in the study will receive INCLISIRAN and the other half will not receive a study treatment but will be monitored. You will be in the study for one year and seen in the office five times during this time period. Blood samples, ECG’s, vital signs and questionnaires will be completed.

Study Team: Dr. Marlo Leonen. Kristina Wippler, RN, BSN.

The study is being done to determine if a medication called INCLISIRAN can safely and effectively prevent cardiovascular events in the future (such as heart attacks, strokes, cardiovascular-related death, or procedures to improve blood flows (also called “revascularization”)) by lowering LDL-cholesterol in the blood.

To qualify for the study, you must:

• Be at risk for having a cardiovascular event
• Have a high LDL-cholesterol

If you decide to participate, there will be certain tests/questionnaires you must complete to find out if you meet the requirements to be in the study. One half of the participants in the study will receive INCLISIRAN and the other half will not receive the study treatment but will be monitored. You will most likely be in the study for approximately 6 years. During this time, you will be seen in the office 4 times in the first year. After the first year, you will be seen every 6 months (twice a year). Blood samples, vital signs, and questionnaires will be completed during clinic visits.

Study Team: Ahmad Mizyed, MD. Bozhena Stakh, RN.

The study is being done to determine if a medication call INCLISIRAN, taken in addition to statin medication in people with established cardiovascular disease, can safely and effectively lower the risk of cardiovascular events in the future (i.e. heart attacks, strokes, and cardiovascular-related deaths)

To qualify for the study, you must:

• Have been diagnosed with a cardiovascular disease
• Be currently taking a statin medication

If you decide to participate, it is very important that you continue to take your statin medication. One half of the participants in the study will receive INCLISIRAN and the other half will not receive the study treatment but will be monitored. You will most likely be in the study for approximately 3-6 years depending on when you enter the study. During this time, you will be seen in the office 4 or 7 times in the first year. After the first year, you will be seen every 6 months. Blood samples, vital signs, and questionnaires will be completed.

Study Team: Ahmad Mizyed, MD. Sarah Whitsett, RN.

This study is being done to compare the effects of a study drug called obicetrapib vs. placebo to find out if obicetrapib is helpful for treating atherosclerotic cardiovascular disease and reducing the risk of major cardiovascular events when taken with existing medication.

To qualify for the study, you must:

• Have been diagnosed with atherosclerotic cardiovascular disease (ASCVD).
• Have a high level of Low-Density Lipoprotein Cholesterol (LDL-C) in your blood.

If you are eligible and decide to participate in the study, you will be randomly assigned in a 1:1 fashion (50% chance) to receive either obicetrapib or placebo. Study procedures will be performed during four stages of this study: Screening, Study Treatment Period, End of Study Treatment (or Early Termination) and Follow-up Period.

This is an event-driven study, which means that it will complete after a certain number of cardiovascular events have occurred in the whole population of study participants, but no sooner than 32 months after you start the study. Therefore, your participation in this study will last at least 32 months and include around 14 study visits. Blood samples and ECGs will be completed during certain study visits.

Study Team: Ahmad Mizyed, MD. Kristy Wippler, RN, BSN.

The study is being done to determine whether Intensive Cardiac Rehabilitation (ICR) provides more health benefits and lower costs compared to Conventional Cardiac Rehabilitation (CCR).

To qualify for the study, you must:

• Have had a cardiac event
• Have been referred to cardiac rehabilitation

If you decide to participate and meet the eligibility requirements, you will be placed into one of three different study groups. You have an equal chance of being randomized into one of the three study groups: Convention Cardiac Rehabilitation (CCR), Intensive Cardiac Rehabilitation (ICR), Intensive Cardiac Rehabilitation (ICR) Plus Food. You will complete questionnaires, have blood draws three times, and have a buccal (cheek) swabbing performed two times during the study. You will be involved in this research study for approximately 2 years.

Study Team: Frank Smith, MD. Autumn Howe, RN.

This study will test whether the drug dapagliflozin is safe and has beneficial effects when added to conventional heart failure therapy in patients who have been admitted to the hospital for acute heart failure and whose heart pumping function is weakened.

To qualify for the study you must have:

• Been hospitalized with a heart failure.
• A reduced pumping ability of your heart muscle (ejection fraction less than or equal to 45%).

If you are eligible to take part in the study, you will be randomized to receive either dapagliflozin tablet or placebo tablet. You will have a 50% chance of receiving dapagliflozin or 50% chance of receiving placebo. You will not know what drug you are receiving.

The study medication will start while you are in the hospital. You will be seen at 1 week, 1 month and 2 months in the research office.

Study Team: Dr. Marlo Leonen. Kristy Wippler, RN, BSN.

The study is being done to determine if a medication called ziltivekimab can be used to treat people living with heart failure and inflammation.

To qualify for the study, you must:

• Be diagnosed with heart failure and have limitations in your daily life because of the disease
• Have inflammation in the body

If you decide to participate, you will either receive ziltivekimab (the new medicine being tested) or placebo (an inactive dummy medicine). The study medicine you get is decided by chance (like flipping a coin). You will get your study medicine as an injection. You will need to inject the study medicine into the skinfold in your stomach, thigh, or upper arm once every month. The study is expected to last for up to 4 years. During this time, you may be asked to come to clinic for up to 20 visits. A study app (on your personal phone or provided study phone) will be used to record and share information about all your injections. The study app will also be used to complete questionnaires. Some clinic visits may include blood draws and electrocardiograms.

Study Team: Mansoor Qureshi, MD. Kara Sawaya, RN.

The purpose of this study is to find out if using mononuclear cells (MNCs) from your own bone marrow will improve your symptoms of heart failure by showing improvement in the 6-minute walk test.

To qualify for the study you must have:

• Had a previous heart attack.
• Been told that you have heart failure.

If you decide to participate, you will go through a screening period to find out if you qualify for the study. Qualifying patients will be scheduled for the procedure and randomized (assigned by chance) into one of 2 groups. 60% receive the treatment and 40% will be in the control group and will not receive the MNC injections. You will not know what group you are in. You will be seen at 1, 3, 6, 9 and 12 months with yearly visits for 2 years.

Study Team: Dr. Zakir Sahul. Nora Marchelletta, RN, BSN.

This study is being done to assess whether remote monitoring of vital signs (blood pressure, pulse, respiratory rate, oxygen levels, weight) and use of a cloud-based clinical support tool (mobile study application or “app”) can improve prescribing and dosage increases of medications used in the treatment of heart failure.

To qualify for the study you must have:

• Have been diagnosed with heart failure.
• Have a reduced pumping ability of your heart muscle (ejection fraction less than or equal to 40%).

If you are eligible and decide to participate in the study, you will have a 50% chance of being enrolled in the intervention group or the control group (which involves standard treatment of your heart failure). Participants randomized to the intervention group will be remotely monitored for 90 days. A mobile study application (“app”) will be utilized to manage your heart failure medications based on standard clinical guidelines. You will be in the study for approximately 180 days.

Study Team: Ahmad Mizyed, MD. Nora Marchelletta, RN.

This study is being done to test if closing off the heart’s left atrial appendage (LAA) with a surgical device, known as the AtriClip, reduces stroke occurrence in patients who do not have atrial fibrillation (AF) but who have one or more risk factors for developing AF in the next 5 years.

To qualify for the study, you must:

• Be scheduled to have heart surgery.
• One or more risk factors for developing AF in the next 5 years.

f you decide to participate, you will undergo certain study assessments (blood draws, physical exams) to determine your eligibility for the study. If your doctor determines that you qualify, your involvement will last at least 5 years and possibly up to 10 years. Eligible participants will be randomly assigned in one of two treatment groups: Group 1 (LAA closure using AtriClip during heart surgery) and Group 2 (no LAA closure during heart surgery). After the procedure, a series of follow-up visits will occur to monitor your health. You will continue to receive study follow-up care unless you decide to withdraw from the study, or the sponsor stops the study.

Study Team: Robert Lyons, MD. Megan Thompson, RN.

This study is being done to determine whether CCM therapy delivered by the Optimizer System can improve outcomes in patients with heart failure.

To qualify for the study, you must:

• Be diagnosed with symptomatic heart failure
• Have a recent heart failure hospitalization or urgent heart failure visit requiring IV therapy

If you qualify and decide to participate in this study, you will undergo implantation of the OPTIMIZER® device. You will then be randomly placed into one of two study groups. The decision about which group you will be in will be based on chance, like flipping a coin. Neither you nor your doctor will know which group you have been assigned.

1. ACTIVE GROUP: You will have a 2/3 chance of having CCM® turned ON
2. CONTROL GROUP: You will have a 1/3 chance of having CCM® turned OFF

After the 18-month blinded phase of the trial is completed, you will begin the unblinded phase of the trial. If you were in the CONTROL group with CCM® OFF, you will have CCM® therapy turned ON at this time so all devices will have CCM® turned ON after the blinded phase. The long-term follow-up period is required so that we can continue to monitor your device and safety events while enrollment and follow-up is completed for all participants and the FDA has made a decision regarding the safety and efficacy of CCM® therapy in patients with HF(40-60)pEF. This long-term follow-up period could last more than 5 years, depending on when you are enrolled.

Study Team: Ahmad Mizyed, MD. Autumn Howe, RN.

This study is being done to evaluate the safety of long-term use of the Optimizer System and CCM therapy for patients who have already made the decision to have the Optimizer system implanted. The post approval study (PAS) will also evaluate the effects of CCM therapy on your quality of life and heart failure symptoms, as well as your heart’s ability to pump effectively and some potential blood related chemical changes.

To qualify for the study, you must:

• Be diagnosed with symptomatic heart failure
• Have a doctor believe you may benefit from a new FDA-approved heart failure therapy called cardiac contractility modulation (CCM therapy)

If you decide to participate, most of the procedures and assessments performed in this study will be no different than if you were to receive the Optimizer System without participating in this study. In some cases, results from assessments already recorded in your medical record may be used and for others, standard of care assessments shall be conducted. Some procedures and assessments will be performed for study purposes only (questionnaires, possible blood draws, ECGs, and echocardiograms). You will be in the study for approximately 3 years or until no further information is required for this study.

Study Team: Jihn Han, MD. Autumn Howe, RN.

This study is being done to determine if early study treatment with the medicine, dronedarone, is more effective than usual care alone for the prevention of unplanned cardiovascular hospitalization (such as hospitalization for heart failure, atrial fibrillation, stroke, heart attack, or death from any cause) in patients presenting to the hospital with first-detected atrial fibrillation (AFib).

To qualify for the study you must have:

• Have first-detected AFib (defined as AFib diagnosed in the previous 60 days).
• Have electrocardiographic documentation of atrial fibrillation.

If you are eligible and decide to participate in the study, you will be randomized 1:1 (50% chance) to receive either the study intervention (dronedarone plus usual care for atrial fibrillation), or usual care alone, without dronedarone.

You will be in the study for approximately 12 months with follow-up visits occurring at 6 months and 12 months.

Study Team: Andrew Hughey, MD

The study is observing the safety and effectiveness of the Indigo Aspiration System. This study will help determine how study participants recover when the study device is used to treat deep vein thrombosis (DVT).

To qualify for the study, you must:

• Have a blood clot in one or more of the deep veins in one of your legs.
• Be willing to receive treatment with the Indigo Aspiration System.

If you are eligible to participate, you will have a baseline visit before you are treated for your DVT. This will require hospital staff to perform routine tests and procedures to evaluate the severity of your DVT and your general state of health (including routine imaging, blood samples, and assessments). Should the study doctor decide to remove the clot, you will receive treatment with the Indigo Aspiration System. After being discharged from the hospital, you will have 4 follow-up visits (occurring at 30 Days, 180 Days, 12 Months, and 24 Months post-procedure) where the study doctor/coordinator will collect information as part of your routine care. This may include laboratory tests, assessments, and imaging. It is expected that you will be in the study for approximately 2 years.

Study Team: Michael Sarosi, MD. Sarah Whitsett, RN.

The purpose of the study is to find out how effective and safe CSL112 is at reducing the risk of dying from heart related events, having another heart attack, or having a stroke. Studies have shown that a protein in the body called apolipoprotein A-I (ApoA-I) may help to remove excess cholesterol from the arteries. CSL112 resembles HDL, which is sometimes better known as the ‘good cholesterol’.

To qualify for the study you must have:

• Been hospitalized with a recent heart attack
• Blockages or narrowing in more than one blood vessel in your heart.

If you are eligible to take part in the study, you will be randomized to receive either the CSL 112 or placebo. You will have a 50/50 chance of receiving either CSL112 or placebo.

The study drug will be given by intravenous (IV) infusion over 2 hours. You will receive up to four (4) infusions of study drug weekly for 4 weeks. All 4 infusions should be administered within 30 days of receiving your first infusion. Additional study visits will occur throughout the next year to assess for any new health problems, side effects, or changes in your medical conditions.

Study Team: Dr. David Sutter. Megan Thompson, RN, BSN.

The purpose of this study is to look at the effectiveness of the implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy pacemaker/defibrillator (CRT-D) devices in treating life threatening fast heart rhythm disorders and preventing death in the patients with heart failure due to non-ischemic (not due to coronary artery disease) cardiomyopathy.

To qualify for the study you must have:

• Heart failure due to non-ischemic cardiomyopathy.
• Been told you need or currently have an implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy pacemaker/defibrillator (CRT-D) device to prevent sudden death.

If you decide to participate, the study doctor will determine if you qualify for the study. You will be scheduled for the implant procedure. The follow up is in office yearly for 3 years. You will also have home monitoring follow up visits at 6, 18 and 30 months.

Study Team: Dr. Srinivas Hebsur. Autumn Howe, RN, BSN.

The purpose of the study is to understand the value of ATP (anti-tachycardia pacing) in patients who have not yet received a shock from their defibrillator (primary prevention patients). ICD’s or defibrillators are implanted in certain patients who are at an increased risk of sudden cardiac death from fast and life threatening heart rhythm disorders. This study is to see if certain programing by ATP will reduce the number of shocks received and improve survival in such patients.

To qualify for the study you must have:

• Been implanted with an ICD (implantable cardioverter defibrillator) for the treatment of a potentially fast or life-threatening heart rhythm disorder.
• Meet the guidelines for primary prevention.

If you decide to participate, you will be randomized into one of two groups. Group one will have the ICD programed to deliver ATP treatment first and then only deliver a shock if needed. Group two will have their device deliver a shock only without ATP. Your follow up visits will be in the office yearly and your device will be checked every 6 months for up to five years.

Study Team: Dr. Jihn Han. Autumn Howe, RN, BSN.

The purpose of this study is to compare the efficacy (how well it works) and safety of the Firehawk stent to other FDA approved drug eluting heart stents (DES). The drug eluting stent is a special coated stent that releases a drug which helps prevent blockages from coming back.

To qualify for the study:

• Your physician has determined that you may need to receive a stent in one or more arteries in your heart.
• Ejection Fraction (pumping function of the heart) greater than 30%.

If you qualify, you will be randomized to one of two groups. One group will receive the Firehawk stent and the other group will receive the currently FDA approved drug eluting stent. The study team will call you at 30 days, 6 months, 2, 3, 4, and five years. You will be seen in the office at one year.

Study Team: Dr. Zakir Sahul. Megan Thompson RN, BSN

The purpose of the study is to determine at what red blood cell count patients should be given a transfusion in order to lower the risk of death, heart attacks and other health problems.

To qualify for the study you must have:

• Been hospitalized with a recent heart attack.
• A red blood cell count of less than 10g/dl.
• Be willing to accept a blood transfusion

If you decide to participate, you will be placed into one of 2 different study groups. The decision of which group is based on chance like flipping a coin. One group will receive blood transfusion immediately and the other group will not receive a blood transfusion unless the red blood count drops below 8g/dl or if your physician believes it is in your best interest to receive blood.

Study Team: Dr. Mansoor Qureshi. Kristina Wippler RN, BSN

The purpose of this study is to see if vagus nerve stimulation can improve the pumping function of the heart and reduce heart failure symptoms. Patients who have chronic heart failure have an imbalance in the nerves that stimulate the heart essentially keeping the heart in “overdrive” which can worsen the heart failure and symptoms over time. Previous studies have shown that stimulation of the vagus nerve with this special device may improve pumping function and symptoms related to heart failure.

To qualify for the study you must have:

• Symptomatic heart failure with an ejection fraction of less than or equal to 35%.
• Not received or intended for cardiac resynchronization therapy.

If you decide to participate you will be randomized, like flipping a coin. There are 2 chances out of 3 to be implanted with the device that includes a pulse generator (battery) and a wire. This is a computer controlled device much like a cardiac pacemaker. This sends signals to the heart and brain by stimulating the vagus nerve. You have a 1 out of 3 chance of being assigned to standard medical therapy. All patients will be seen in follow up by the study team at 4 weeks, 3, 6, 9, 12 and 16 months and every 4 months for up to 5 years.

Study Team: Dr. Ahmad Mizyed. Autumn Howe, RN, BSN.

This study is being done to evaluate the safety and effectiveness of renal denervation while you are still on your blood pressure medications. The purpose of the treatment (renal denervation) is to lower blood pressure. Therefore, the effectiveness of the study catheter together with the alcohol (Peregrine Kit) will be assessed by how well the treatment reduces your blood pressure.

To qualify for the study, you must:

• Be diagnosed with high blood pressure (hypertension)
• Be taking multiple medications to treat your high blood pressure

If you decide to participate, you will undergo certain screening procedures (MRA/CTA with contrast, ECG, physical examination, blood draws) to determine your eligibility for the study. The Screening Period maybe as short as a single day/visit, but no more than 8 weeks. Once your eligibility is confirmed, you will proceed to the Run-In Period (approximately 4 weeks prior to your scheduled procedure). During the Run-In Period (and 3 months after your procedure), you’ll be responsible for recording your blood pressure (using an automated blood pressure device that will be provided) twice a day and recording results in a subject diary. Clinic visits could also include questionnaires and surveys. On the day of the procedure, there is a 50% chance that you will be assigned to the Treatment Group (receiving the experimental renal denervation with the Peregrine Kits procedure), and a 50% chance that you will be assigned to the Control Group (not receiving renal denervation). After the procedure, you will enter the Follow-up Period which consists of at least 9 clinic visits. You will be in the study for approximately 40 months with a total of about 15-20 in-person clinic visits.

Study Team: Mansoor Qureshi, MD. Kristy Wippler, RN.

The purpose of this trial is to find out if a drug called empagliflozin, in addition to usual or standard care, will reduce the risk of heart failure and death in patients who had a heart attack (myocardial infarction). Empagliflozin has not been approved for your specific condition but it has been approved by the FDA for other uses. It has been approved by the FDA (brand name Jardiance®) to treat type 2 diabetes and to reduce the risk of cardiovascular death in adult patients with type 2 diabetes and established cardiovascular disease.

To qualify for the study you must have:

• Been told you have had a heart attack and hospitalized within the past 14 days.
• Be at high risk for heart failure or have an ejection fraction (pumping function of the heart) less than 45%.

If you decide to participate, you will be placed into one of two different study groups. You will be randomly assigned to receive either the placebo (no active drug) or empagliflozin the active drug. The decision about which group you will be in will be based on chance, like flipping a coin. This process is called randomization. You will not know which research drug/intervention you are receiving, and neither will your study doctor. You will complete a screening visit, randomization visit and a 2 week follow up visit with the study staff. At 6 months you are seen in the office. Thereafter, you will be contacted by the study staff every six months for up to two years.

Study Team: Dr. David Sutter. Megan Thompson, RN, BSN.

The purpose of this study is to evaluate improvement from baseline in patients with heart failure and atrial fibrillation. This is an observational study to gather information about the benefits of cardiac resynchronization therapy (CRT) in adults with heart failure and atrial fibrillation who are being treated with the BIOTRONIK CRT-DX system per your doctor’s standard of care. Your overall health is measured by looking for improvement in atrial fibrillation (AF), physical fitness, and general quality of life. The BIOTRONIK CRT-DX system and its device components are approved by the U.S. Food and Drug Administration (FDA). They are legally marketed in the United States and are not investigational devices.

To qualify for the study you must have:

• Symptomatic heart failure and standard CRT-D indication according to current guidelines.
• A documented history of paroxysmal, persistent, or long-standing persistent atrial fibrillation (AF).

Been successfully implanted with a BIOTRONIK CRT device.
If you decide to participate, you will complete study questionnaires about your health, complete a six-minute walk test, and electrocardiograms (ECG) to determine your heart rhythm throughout. Study visits occur at the time of enrollment, the day of the implant procedure and in office at 3, 6 and 12 months. Your total participation is one year.

Study Team: Dr. Jihn Han and Autumn Howe, RN, BSN

This study is being done to compare which water pill, furosemide or torsemide, is best for patients hospitalized for heart failure.

To qualify for the study you must have:

• Been hospitalized with heart failure.
• A reduced pumping ability of your heart muscle (ejection fraction less than or equal to 40%).

If you are eligible and decide to participate in the study, you will be randomized 1:1 (50% chance) to receive either furosemide or torsemide. You will start the medication before you are discharged from the hospital.

You will receive a follow up phone call from DCRI call center research staff at 30 days and every 6 months for up to 30 months. They will ask how you are doing and what medications you are taking.

Study Team: Dr. Ahmad Mizyed. Kara Sawaya, RN, BSN

The purpose of this study is to determine if study drug ISIS 757456 weekly injections will decrease the production of angiotensinogen concentration in the patients with heart failure and reduced ejection fraction. Patients with heart failure are commonly treated with medications that block activity of hormones that may make your heart failure worse. The study drug is designed to lower the activity of these hormones by lowering the amount of a protein called angiotensinogen in your blood.

To qualify you must have:

• A reduced pumping ability of your heart muscle (ejection fraction of 40% or less).
• Been taking diuretics (water pills) for at least four weeks.

If you decide to participate you will have blood work drawn to see if you qualify. You will be randomized 2:1 (you will have 2 chances out of 3) to receive either study drug or placebo. The study drug is given by injection under the skin weekly for 12 weeks. You will complete a questionnaire, have electrocardiograms (ECG), blood work and your vital signs taken throughout the study. The study team will continue to see you after study drug completion for an additional six visits. Total study participation is six months.

Study Team: Dr. Ahmad Mizyed. Nora Marchelletta RN, BSN

The purpose of the study is to assess the effects of sacubitril/valsartan (Entresto), verses valsartan in changes in NTproBNP, safety and tolerability in patients who have heart failure with preserved ejection fraction (pumping function), HFpEF.

HFpEF occurs when your heart muscle contracts normally but the ventricles, or heart chambers do not relax as they should because of increases stiffness of the heart muscle. NTproBNP blood test reflects the elevated pressures or stress on your heart.

To qualify you must have:

• Been hospitalized with heart failure.
• Ejection fraction greater than 40%.
• Blood test showing stress on your heart.

Qualifying patients will be randomized to receive the sacubitril/valsartan (Entresto) or valsartan. You will have a 50% chance of receiving either study drug or placebo. You will not know what drug you are receiving. You will be taking 2 tablets twice a day.

You will have frequent office visits to see how you are doing, measure your blood pressure, and to obtain blood and urine samples. Your participation in the study could last up to 20 months or as little as 2 months.

Study Team: Dr. Marlo Leonen. Kara Sawaya, RN, BSN.

The purpose of this study is to test a new way to pace (stimulate heart muscle contraction) the left side of the heart, without the use of standard pacing leads, by using the WiSE CRT System along with your currently implanted cardiac device.

When the pumping ability of the heart is reduced, this results in a condition known as heart failure. Patients with heart failure may benefit by pacing both ventricles at the same time, thus improving your heart's pumping ability. This therapy is called bi-ventricular pacing or cardiac resynchronization therapy (CRT).

To qualify for the study you must have:

• Been implanted with a CRT system but the left ventricular lead is not functioning properly.
• Had a CRT system implant attempted without success.
• A reason why a standard CRT system is not an option for you.

You will have an echocardiogram (heart ultrasound) to be sure you are a good candidate for the study device. If you qualify, you will have the device implanted at the hospital and will be admitted for an overnight stay. You will be seen for study visits at 1, 3, 6, 12 and 18 months and at 2, 3, 4, and 5 years thereafter.

Study Team: Dr. Edwin Zishiri. Autumn Howe, RN, BSN.