The Utah Artificial Heart Program at Intermountain Medical Center is a forerunner in research. In order to improve the quality of care for our patients, we have a dedicated team of engineers and researchers who study the medical care and outcomes of each patient. Results from this research have been instrumental in influencing the medical practice for patient care and improving artificial heart technology.
In addition to original research, the UAHP has participated in over 15 clinical device trials. As the number one enrolling center for the REMATCH (Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure) Trial, the UAHP helped prove that LVAD therapy is superior to optimal medical therapy for treating end-stage/advanced heart failure patients.
The REMATCH trial has led to the UAHP to become involved in many other studies, including the HeartMate II Bridge to Transplant and Destination Therapy Trials and the HeartWare Destination Therapy Trial.
Enrolling Trials
For more information on our clinical trials, please contact us.
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.
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.
Trial: CentriMag – RVAS
Long Title: CentriMag RVAS U.S. Post Approval Study
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.
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, you must be implanted with the TAH-t and your health must have stabilized after the surgery so that your doctor feels that it may be possible for you to go home while implanted with the TAH-t and supported by the Freedom Driver.
Title: Syncardia temporary Total Artificial Heart (TAH-t) 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 temporary Total Artificial Heart (TAH-t) is implanted at trained hospitals 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, patients 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.
Publications
As part of our pioneering efforts to expand this challenging field, the Utah Artificial Heart Program has had the privilege of collaborating with other implanting LVAD centers, gathering important data, and sharing research findings, which have been published in various journals.
Click on the link below to download a comprehensive list of publications by the Utah Artificial Heart Program over the past 10 years.
2010 Original Research Publications:
- Bishop CJ, Mason NO, Kfoury AG, Lux R, Stoker S, Horton K, Clayson SE, Rasmusson B, Reid BB. A novel non-invasive method to assess aortic valve opening in HeartMate II left ventricular assist device patients using a modified Karhunen-Loève transformation. J Heart Lung Transplant. 2010;29(1):27-31.
- Mason NO, Reid BB, Harmstan G, Jones J, Stoker S, Budge D, Alharethi R, Thomsen G, Clayson SE, Caine WT, Kfoury AG, Characterization of gastrointestinal bleeding in HeartMate II left ventricular assist device patients. J Heart Lung Transplant. 2010;29(2):S175. (Abstract).
- McCormick AJ, Reid BB, Budge D, Clayson SE, Revenaugh JR, Stoker S, Raymond AL, Smith HK, Doty JR, Caine WT, Alharethi R, Kfoury AG. Versatility and patient outcomes with the Levitronix CentriMag temporary ventricular assist device. J Heart and Lung Transplant. 2010;29(2):S100. (Abstract).
- Ventura PA, Reid BB, Horne BD, Mason NO, Stoker S, Alharethi R, Budge D, Rasmusson B, Doty J, Clayson SE, Kfoury AG. Differential impact on post-transplant outcomes between HeartMate XVE and HeartMate II left ventricular assist devices. J Heart and Lung Transplant. 2010;29(22):S99. (Abstract).
- Raymond AL, Kfoury AG, Bishop CJ, Davis ES, Goebel KM, Stoker S, Selzman CH, Clayson SE, Smith HK, Cowley CG, Alharethi R, Budge D, Reid BB, et al. Obesity and left ventricular assist device driveline exit site infection. ASAIO Journal. 2010;56:57-60.
- Mason N, Bishop CJ, Kfoury AG, Lux R, Crawford C, Horne B, Stoker S, Clayson SE, Rasmusson B, Reid BB, et al. Noninvasive predictor of HeartMate XVE pump failure by neural network and waveform analysis. ASAIO Journal. 2010;56:1-5. (Abstract).
- Ventura PA, Mason NO, McCormick AJ, Ledford ID, Reid BB, Budge D, Alharethi R, Stoker S, Smith H, Kfoury AG. Outcomes with the Levitronix CentriMag as cardiopulmonary support for cardiogenic shock. ASAIO Journal. 2010;56:103. (Abstract).
- McCormick AJ, Ledford ID, Mason NO, Reid BB, Clayson SE, Alharethi R, Stoker S, Budge D, Kfoury AG. Time-dependent differences in the cause of death after left ventricular assist device implantation. ASAIO Journal. 2010;56:115. (Abstract).
- Mason NO, Sorenson M, Ledford ID, Johnson D, Young S, Reid BB, Clayson SE, Stoker S, Alharethi R, Budge D, Kfoury AG. Characterization of reasons for turning down referrals for left assist devices (LVADS). ASAIO Journal. 2010;56:90. (Abstract).
- Ledford ID, McCormick AJ, Mason NO, Ventura PA, Reid BB, Rasmusson B, Budge D, Stoker S, Kfoury AG, Alharethi R. Clinical predictors for long hospital stay after left ventricular device (LVAD) implantation. ASAIO Journal. 2010;56:110. (Abstract).