John M. Stulak, M.D.

The purpose of this study is to use prospectively collected digital recordings of cardiac surgery operations from the Surgical Team View (ST) camera and the Operating Team View (OT) camera, of the surgical team and the operating room team and for research purposes. Technical assessments will be linked to surgeons clinical outcomes to improve to try and find improvements that may assist more positive outcomes. 

This is a prospective, randomized, controlled, unblinded, multi-center evaluation of the stroke incidence in patients implanted with a HeartWare HVAD who receive optimal blood pressure management. The study compares results of stroke incidence in a new cohort of subjects receiving optimal blood pressure management to a reference stroke incidence observed in the original IDE clinical trial (HW004) that did not specify optimal blood pressure management. In addition, a secondary endpoint will evaluate non-inferiority of stroke-free success on the originally implanted device to a control group (i.e. any FDA-approved LVAD for destination therapy). Subjects will be randomized to HeartWare HVAD or control LVAD in a 2:1 ratio. Each subject receiving the HeartWare HVAD or control LVAD is followed to the primary and secondary endpoints at 12 months, with a subsequent follow-up period extending to 5 years post implant.

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.

This is a prospective, multi-center,single arm study that will evaluate the thoracotomy implant technique in up to 120 subjects implanted via thoracotomy with the HeartWare HVAD® System and enrolled in the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS®) protocol and database. All participating centers will be current INTERMACS® sites in good standing and will follow the INTERMACS® protocol and procedures.

The purpose of this product surveillance registry (PSR) study is to provide continuing evaluation and and periodic reporting of safety and effectiveness of market-released products for their intended use.

This is a prospective, interventional, multi-center trial to report the overall incidence of reduced leaflet motion identified by CT imaging in patients receiving a commercially approved LivaNova bioprosthetic aortic heart valve up to 1 year post implant.

The purpose of this research study is to look at the advantages of using a 3D printed heart model for surgical planning in children who have been diagnosed with Congenital Heart Disease (CHD) and clinical heart failure and will undergo a ventricular assist device (VAD) placement. The investigators want to study the correlation of having a 3D printed model with improvement in patient outcomes and compare those with patients who have had a VAD placement without a 3D model.

The purpose of this study is to continue to evaluate the safety and clinical performance of the HeartMate MOMENTUM 3 left ventricle assist system for the treatment of advanced, refractory, left ventricular heart failure following completion of participation in the the MOMENTUM 3 IDE study.

The primary purpose of this study is to report the composite endpoint of survival to transplant, recovery, or LVAD support free of debilitating stroke (Modified Rankin Score > 3) or reoperation to replace the pump at 5-years post-implant in subjects who were implanted with the HM3 or HMII LVAS in the MOMENTUM 3 IDE trial and are ongoing at the 2-year follow-up.

The purpose of this study is to assess how often blood clots form in the FDA-approved HeartMate® II (HM II) Left Ventricular Assist Device (LVAD) and to identify risks related to clotting within the pump.

This study is a prospective, multi-center, randomized, double-blind placebo-controlled study of subjects receiving the HM II LVAD as per the current FDA approved indications for use.

The purpose of this study is to evaluate the effectiveness of the PleuraFlow® Active Clearance Technology™ (ACT) System in the management of blood evacuation after cardiac surgery.

The main purpose of this research is to determine whether injecting mesenchymal precursor cells (MPC) into the heart during surgery to implant a left ventricular assist device (LVAD) is safe. MPCs are normally present in human bone marrow and have been shown to increase the development of blood vessels and new heart muscle cells in the heart. In addition, this research is being done to test whether injecting the MPCs into the heart is effective in improving heart function.

The objective of the study is to evaluate the safety and effectiveness of the HM3 LVAS by demonstrating non-inferiority to the HMII LVAS (HMII) when used for the treatment of advanced, refractory, left ventricular heart failure.