The HeartWare HVAD Pump is a miniaturized left ventricular assist device that is implanted in the pericardial space adjacent to the heart, and may be implanted in small adults and adolescents.
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If you would like specific information about one of our clinical trials, please call (801) 507-4701.
Before we decide to participate in a new study, each trial goes through an extensive safety and scientific review by our physicians and scientists on the Cardiovascular Scientific Review Board.
Trial: ENDURANCE
Long Title: A Clinical Trial to Evaluate the HeartWare® Ventricular Assist System
Principal Investigator: Bruce Reid, MD
Sponsor: HeartWare, Inc.
Description: This study evaluates the use of the HeartWare Ventricular Assist System for Destination (permanent) Therapy patients with advanced heart failure. Participants receiving this device may not be candidates for heart transplant.
For More Information: (801) 507-4701
Trial: FREEDOM
Long Title: SynCardia Freedom Driver System Study
Principal Investigator: Stephen E. Clayson, MD
Sponsor: SynCardia Systems Inc.
Description: The purpose of this study is to determine if the Freedom Driver System (a pneumatic pump) will sufficiently support the Total Artificial Heart (TAH-t) in clinically stable patients. The second purpose of this study is to see if non-medical people, the patients and caregivers, can be trained to manage the Freedom Driver System safely outside the hospital while the patient waits for a heart transplant. In order to be in this study, patients must be implanted with the TAH-t. In addition, their health must be stable enough after surgery for their doctors to feel it may be possible for them to go home while implanted with the TAH-t and supported by the Freedom Driver.
For More Information: (801) 507-4701
Trial: CentriMag – Failure to Wean
Long Title: Levitronix CentriMag VAS Failure-to-Wean from Cardiopulmonary Bypass
Principal Investigator: Stephen E. Clayson, MD
Sponsor: Levitronix LLC
Description: This study is specifically designed for patients who are unable to come off cardiopulmonary bypass after their cardiac surgery. This study evaluates the CentriMag device which helps support patient's hearts while they are recovering in the hospital. All participants in this study must be at least 18 years of age and need heart support after their cardiac procedure.
For More Information: (801) 507-4701
Trial: CentriMag – RVAS
Long Title: CentriMag RVAS U.S. Post Approval Study (PAS)
Principal Investigator: Stephen E. Clayson, MD
Sponsor: Levitronix LLC
Description: This study evaluates the CentriMag device when used to support the right side of the heart. The device helps support patients who develop right heart failure. All participants in this study must be at least 18 years of age and need heart support for right heart failure.
For More Information: (801) 507-4701
Title: Total Artificial Heart Post Market Surveillance Study
Principal Investigator: Stephen E. Clayson, MD
Sponsor: SynCardia Systems, Inc.
Description: This study is being conducted to evaluate whether the patient results achieved when the Total Artificial Heart (TAH-t) is implanted at hospitals that are trained are the same as the patient results that were achieved during the clinical trial that led to the TAH-t being approved by the FDA. In order to participate in this study you must be implanted with the TAH-t. This is a registry study which involves historical data collection, neurology tests and two brief follow up phone conversations after patients have received a heart transplant.
For More Information: (801) 507-4701
Trial: CABANA
Long Title: Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation Trial
Principal Investigator: Jared Bunch, MD
Sponsor: National Institutes of Health
Description: This study compares the efficacy of medications versus catheter ablation procedures for the treatment of patients with persistent atrial fibrillation. Half of the participants of this study will take medications and half will undergo catheter ablation procedure. The purpose of this trial is to determine how patients respond to the two types of treatments. Patients may be eligible to participate in this study if they have persistent cardiac arrhythmia.
For More Information: (801) 507-4701
Trial: PREVAIL
Long Title: Evaluation of the Watchman LAA Closure Device in Patients with Atrial Fibrillation versus Long-term Wafarin Therapy
Principal Investigator: Brian Whisenant, MD
Sponsor: Atritech
Description: Cardiologists at Intermountain Medical Center have been leading participants in both the PROTECT AF Trial and the CAP Registry. These trials have demonstrated the safety and effectiveness of the Atritech Watchman Left Atrial Appendage closure device. The PREVAIL trial is an extension of the PROTECT AF and CAP studies. The goal of the PREVAIL study is to compare the effectiveness of the WATCHMAN Device versus standard medical treatment, warfarin, as an alternative for prevention of AF related stroke. Patients with non-valvular atrial fibrillation may be eligible to participate in this study. The device is investigational technology
For More Information: (801) 507-4701
Trial: GIFT
Long Title: Protocol for Genetics-Informatics Trial (GIFT) of Warfarin to Prevent DVT
Principal Investigator: Jeffrey Anderson, MD
Sponsor: National Institutes of Health
Description: The objective of the GIFT trial is to determine ways to improve the safety and efficacy of the medication warfarin. All of the participants in this study will undergo genetic testing and will be randomly assigned to one of two medication dosing groups. Half of the patients in this study will have the amount of warfarin prescribed to them determined by their doctor in the usual way, based on their health history alone. The other half of the patients will have their genetic test results used in combination with their health history to determine the amount of warfarin they will receive. All patients will be followed for about one month. The study will determine if genetic testing assists doctors in prescribing the most effective amount of medication.
For More Information: (801) 507-4701
Trial: Intermountain Heart Collaborative Study
Sponsor: This is original research from the Heart Institute at Intermountain Medical Center. There is no corporate sponsorship.
Description: Much is already known about the relationships between heart disease and smoking, high blood pressure, high cholesterol, and diabetes. However, scientists are still trying to discover the exact role of genetics and other biological influences on how this disease progresses.
Over the past 17 years, we have collected more than 20,000 DNA samples from patients who have been evaluated for heart disease at LDS Hospital and Intermountain Medical Center. We call it the Intermountain Heart Collaborative Study – a tremendous resource for discovering the underlying factors of heart disease. We are continuing to expand and increase our enrollment into this important registry. Over the past three years alone, the use of this registry has resulted in the publication of more than 40 research papers, all of which were published in major international scientific journals! All patients who are 18 years of age or older and enter the cardiac catheterization lab at Intermountain Medical Center are eligible to participate.
For More Information: (801) 507-4701
Trial: FACTOR 64
Long Title: Screening for Asymptomatic Obstructive Coronary Artery Disease Among High-Risk Diabetic Patients Using CT Angiography: A Randomized Control Trial
Principal Investigator: Brent Muhlestein, MD
Sponsor: Toshiba Medical Systems, Bracco Diagnostics, Intermountain Research and Medical Foundation, formerly the Deseret Foundation, and Intermountain Healthcare
Description: This study is evaluating patients with diabetes and no prior, documented evidence of cardiovascular disease. Half of the participants in this study will be randomly chosen to undergo a 64 multidetector Coronary CT or calcium score CT to evaluate their risk for heart disease. The other half of the patients will continue to receive standard treatment for their symptoms by their regular health care providers. The purpose of this study is to determine if testing diabetic patients before they have symptoms of heart disease will result in early identification and treatment of disease, and if the early treatment decreases heart attacks and death caused by coronary artery disease.
For More Information: (801) 507-4701
Trial: SAPHIRE WW
Long Title: Stenting and Angioplasty with Protection in Patients at High-Risk for Endarterectomy
Principal Investigator: James Burke, MD
Sponsor: Cordis Corporation
Description: The purpose of this study is to collect more information on how well patients do after carotid stenting for treatment of their carotid artery stenosis. The common treatment for this condition includes a surgery called carotid endarterectomy. Patients who are at high risk for the surgery may be eligible to participate in this study. All patients will be followed for 30 days following their treatment.
For More Information: (801) 507-4701
Trial: LAPTOP-HF
Long Title: Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy Study
Principal Investigator: Rami Alharethi, MD
Sponsor: St. Jude Medical
Description: This trial is designed to test if an implanted left atrial pressure monitoring device is safe and effective at preventing heart complications. The device lets patients and their doctors know how their heart is performing on a regular basis. It is hoped that this information will allow medical care providers and patients to respond quickly to any changes that may occur. Patients who have been diagnosed with heart failure and have a history of cardiomyopathy for at least 6 months may be eligible for this study.
For More Information: (801) 507-4701
Short Title: ROSE
Long Title: Renal Optimization Strategies Evaluation in Acute Heart Failure
Principal Investigator: A.G. Kfoury
Sponsor: National Heart, Lung, and Blood Institute (NHLBI) and Duke University/Duke Clinical Research Institute
Description: The purpose of this study is to evaluate the safety and efficacy of adjuvant renal-protective therapies with low dose Dopamine and low dose Nesiritide, added to optimal diuretic dosing, in patients with acute heart failure. Patients hospitalized for acute heart failure may qualify for this study.
For More Information: (801) 507-4701
Trial: Partner II Trial
Long Title: Placement of Aortic Transcatheter Valves Trial
Principal Investigators: Brian Whisenant, MD and Kent Jones, MD
Sponsor: Edwards Lifesciences, LLC
Description: The purpose of the PARTNER II trial is to determine the safety and effectiveness of the Edwards SAPIEN XT device and NovaFlex delivery systems in inoperable patients with symptomatic critical aortic stenosis. Patients with critical aortic stenosis who are characterized as high risk for surgery or inoperable may be eligible for this study. The investigational replacement heart valve is compressed on a balloon and delivered to the heart via a catheter inserted into either the femoral artery in the leg (transfemoral) or a small incision between the ribs (transapical). This study is comparing the SAPIEN XT device to the original SAPIEN device used in the PARTNER I trial.
For More Information: (801) 507-4701
Trial: REALISM - EVEREST II Continued Access Registry
Long Title: Real World Expanded Multicenter Study of the MitraClip System
Principal Investigator: Brian Whisenant, MD
Sponsor: Evalve, Inc., a subsidiary of Abbott Vascular
Description: Cardiologists at Intermountain Medical Center participated in the EVEREST II trial which compared the Evalve MitraClip device with standard open heart surgery in patients diagnosed with mitral regurgitation. The MitraClip device is placed via a catheter from the femoral vein and does not require a chest incision, use of a heart-lung machine, or stopping of the heart. The MitraClip device is now available at Intermountain Medical Center through participation in the REALISM registry. Select patients without surgical options may also be considered for emergency use or compassionate use of the MitraClip device.
For More Information: (801) 507-4701
Trial: SPRINT
Long Title: Systolic Blood Pressure Intervention Trial
Sponsor: National Institutes of Health
Description: SPRINT is a clinical trial designed to test whether a treatment program aimed at reducing systolic blood pressure to a lower goal than currently recommended will reduce cardiovascular disease. Over 9000 patients will participate in this study; participants must be age 50 or older, have a systolic blood pressure of equal or greater than 130mm Hg, and at least one other risk factor for heart disease. Patients will be randomly assigned to one of two blood pressure target groups. Their doctor will prescribe medications to help them reach and maintain their target pressure. This study will help determine if maintaining a lower target blood pressure level decreases cardiovascular events, slows the worsening of chronic kidney disease, and slows age-related declines in cognition.
For More Information: (801) 507-4701
Trial: PCN
Long Title: Immune Activation and Myocardial Recovery in Peripartum Cardiomyopathy
Principal Investigator: Rami Alharethi, MD
Sponsor: National Institutes of Health and the University of Pittsburgh
Description: Peripartum Cardiomyopathy (PPCM) is a very rare condition that causes women to have serious heart problems during pregnancy or shortly after giving birth. This study is designed to determine what causes PPCM; it will evaluate immune reactions, genetic make-up, and hormonal fluctuations in patients with this condition. Researchers hope that once the causes are known, treatments and preventative strategies can be used to assist patients and their families.
For More Information: (801) 507-4701