Clinical Trials

The purpose of the study is to evaluate the safety and effectiveness of the ReliantHeart HeartAssist 5® VAD System in patients listed for heart transplantation and at risk of death from refractory end-stage heart failure.

The objective of this registry is to observe short and long term clinical outcomes in heart transplant recipients who receive regular AlloMap testing as part of allograft rejection surveillance.

The objectives of this study is to evaluate the efficacy of Daratumumab as an HLA desensitization strategy prior to cardiac transplantation in highly-sensitized patients.

The purpose of this study is to prospectively evaluate the safety and effectivenes of standard of care, individualized, comprehensive weight loss interventions in carefully selected patients with obesity undergoing cardiac transplant evaluation, including utilization of best lifestyle modifications and guidance to promote a healthy weight, possible medical therapy using FDA-approved weight loss medications and EBMTs with or without concomitant medical therapy.

The purpose of this study is to develop an RNA-seq based peripheral blood assay predictive of inflammation/rejection on allograft biopsy in adult heart transplant recipients.

The purpose of this study is to improve heart transplantation and clinical outcomes for transplant patients. The study will enroll individuals who are scheduled for heart surgery where samples from their heart will be collected as part of the normal surgical procedure.

The purpose of this study is to assess the clinical utility of surveillance using HeartCare testing services, in association with clinical care of heart transplant recipients.

The purpose of this study is o evaluate the effectiveness of the OCS Heart System to resuscitate, preserve and assess hearts donated after circulatory death for transplantation to increase the pool of donor hearts available for transplantation.

The purpose of this study is to enable continued clinical access to DCD heart transplantation in the U.S. and to continue to collect additional data on the performance of the OCS Heart System to resuscitate, preserve and assess hearts donated after circulatory death for transplantation to increase the pool of donor hearts available for transplantation.

The purpose of this study is to obtain electro-anatomic maps of human myocardium in sinus rhythm and ventricular arrhythmias to identify activation patterns, identify and perform tissue ablation at targeted sites of interest that could play an important trigger for development of arrhythmias, and to perform histologic analysis of the myocardial tissue to identify triggers and/or targets for therapies to terminate ventricular arrhythmias.

This study is being done to develop a serum and tissue bank for future research of patients with heart failure, mechanical circulatory support and/or cardiothoracic transplants. This blood/tissue will be used for three principle purposes: (1) laboratory tests which will be available in the future but that are not currently available and which may be of benefit to the patient, (2) review of previous patient laboratory results made necessary by development of a new disease process by the patient, and (3) future unspecified research purposes.

The purpose of this study is to determine if DNA originating from the transplanted heart or lung can be detected in the blood and used to monitor for rejection.

Currently transplant caregivers are viewed as healthy volunteers caring for patients following heart or lung transplant. However research has revealed that thoracic transplant caregivers have increased mood disorders, distress, and high caregiver burden, especially while caring for patients on the organ transplant waiting list. By monitoring caregiver traits and behaviors we will be better able to provide care and services for CG to improve both CG and patient outcomes.

Ability to adhere to complex medical regimens is critical to achieving successful transplant outcomes, as non-adherent patients suffer graft failure and death following transplantation. Since potential recipients greatly exceed organ availability, identification of candidates who will adhere to complex post-transplant regimens is critically important and emphasized by practice guidelines. When selecting candidates for transplant, physicians try to subjectively predict post-transplant adherence because, although tools exist to measure current adherence, tools that reliably predict future adherence are lacking. Despite rigorous medical and psychosocial screening pretransplant, non-adherence rates are high following transplant. Therefore, the current approach for predicting future non-adherence is suboptimal, ...

The purpose of this retrospective and prospective study is to evaluate tissue bank from donors and recipients who underwent heart and lung transplant in order to study the Role of Mitochondrial DNA in Encoding Histocompatibility Antigens in humans and rejection.

The purpose of this study is to collect surgically removed atrial tissue for genetic, pathologic, metabolic, and molecular studies in patients with or without a history of atrial fibrillation.

The purpose of this study is to determine the safety of the SARS-CoV-2 vaccination in patients listed for solid organ transplantation, including heart, lung, liver, kidney, and pancreas.

The purpose of this study is to compare the experienced quality of life of patients who have received both a left ventricular assist device (LVAD), followed by a heart transplant and to measure the results.

The study will prospectively determine the clinical utility of CMV cell-mediated immunity using the Quantiferon test. The investigators will use the assay results to tailor the duration of CMV prophylaxis in solid organ transplant patients.

The purpose of this study is to evaluate the clinical performance of the Aptima CMV Quant assay on the Panther system in ethylenediaminetetraacetic acid (EDTA) plasma samples from solid organ transplantation recipients (SOTR) and hematopoietic stem cell transplant recipients (HSCTR).

The purpose of this study to test the feasibility and safety for autologous (from your own body) skin cells that are manufactured into stem cells of cardiac lineage to be delivered into the heart muscle to determine if those stem cells will strengthen the heart muscle and can be used as an additional treatment for the management of  congenital heart disease. 

The primary research goal of this qualitative study is to explore how patients experience the time between transplant listing and transplantation especially with regards to uncertainty.

Nonadherence to immunosuppression is associated with an increased risk for organ rejection, allograft vasculopathy, and death (De Geest et al., 2014). Immunosuppression nonadherence has been found to be a factor in up to 90% of late acute rejection events that occur after the first year following transplant, and in 13% to 26% of deaths among heart transplant recipients in single-center research studies (De Geest et al., 2005). A prospective cohort study found that for individuals who were nonadherent after their first year following transplant, the risk of a negative clinical event was doubled (Dobbels et al., 2004). In ...

The purpose of this study is to examine the effects of a health coaching intervention on the stress and burden of caregivers of patients awaiting heart or lung transplant.

Hypotheses:  Caregivers will have traits and behaviors pre-transplant that will predict caregiver readiness, quality of life, and transplant recipient outcomes. Specifically, thoracic pre-transplant caregivers report stress, symptoms of anxiety or depression, and perceive high caregiver burden. These factors may be amenable to pre-transplant intervention to improve overall patient and caregiver outcomes.

Aims, purpose, or objectives:  We will conduct a pilot trial to test whether caregivers of heart and lung transplant candidates ...

The purpose of this study is to describe the association between Prospera dd-cfDNA measures and other diagnostic tests used to detect heart allograft rejection and/or njury, including histology, echocardiography and DSA, in the first post-transplant year. Additionally, to inform rates of clinical outcomes in a contemporary cohort of adult heart transplant recipients to determine power for a future randomized, controlled clinical trial.

The aim of this project is to assess the feasibility and utility of a virtual world-based cardiac rehabilitation (CR) program as an extension of a face-to-face conventional CR program (Destination Rehab).