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CLINICAL TRIALS AND RESEARCH
FLIGHT STUDY - The impact of distance from an implanting center on outcomes after left ventricular assist device implantation . Principal investigator : Timothy Gong , MD .
FROZEN AF – A study to evaluate the safety & effectiveness of Boston Scientific cryoablation system for treatment of symptomatic , drug refractory , recurrent paroxysmal Afib . Principal investigator : Alan S . Donsky , MD .
GREAT REGISTRY - A prospective , observational registry to obtain data on GREAT device performance and clinical outcomes for endovascular aortic treatment . Principal investigator : Dennis R . Gable , MD .
GUIDE-HF - Hemodynamic-Guided Management of Heart Failure study evaluates heart failure patients with recent heart failure hospitalizations and NYHA II or III or IV and the effectiveness of the CardioMEMS HF System device . Principal investigator for Dallas site : Shelley Hall , MD .
GUARDIAN REGISTRY - Global Utilization and Registry Database for Improved Heart Preservation . Principal investigator : Dan Meyer , MD .
HEART-FID - Randomized placebo-controlled trial of FCM as treatment for heart failure with iron deficiency . The primary objective of this study is to determine the efficacy and safety of iron therapy using intravenous ( IV ) ferric carboxymaltose ( FCM ), relative to placebo , in the treatment of participants in heart failure with iron deficiency and with a reduced ejection fraction . Principal investigator : Shelley Hall , MD .
HEARTMATE3 PAS - A prospective , multi-center , non-blinded , controlled study intended to evaluate the extended use of the HM3 LVAS compared to the HMII LVAS in those patients that are ongoing at the two-year follow-up in the MOMENTUM 3 IDE trial . Principal investigator : Shelley Hall , MD .
HEARTWARE ENDURANCE – A prospective , randomized , controlled , unblinded , multi-center clinical trial to evaluate the HeartWare™ Ventricular Assist Device System for destination therapy of advanced heart failure . Principal investigator : Dan M . Meyer , MD .
HELIOS-A - A phase 3 global , controlled , open-label study to evaluate the efficacy and safety of ALN- TTRSC02 in patients with hereditary transthyretin amyloidosis ( hATTR Amyloidosis ). Principal investigator : Parag Kale , MD .
HEP C TRANSPLANT COLLABORATIVE – Principal investigator : Shelley Hall , MD .
HLA ANTIBODIES IN BTT – This is a prospective analysis of de novo antihuman leukocyte antigen antibodies production in patients bridged by temporary mechanical circulatory support devices to orthotopic heart transplantation . Principal investigator : Shelley Hall , MD .
HUMANITY - An assessment of Humacyte ’ s Human Acellular Vessel in patients needing Renal replacement therapy : a comparison with ePTFE grafts as conduits for hemodialysis ( HUMANITY ). Principal investigator : Stephen Hohmann , MD .
INNAVASC - This study evaluates the safety and effectiveness of the InnAVasc AVG for hemodialysis access in patients with ESRD . The safety and the effectiveness of the device and the procedure will be assessed using separate primary endpoints through six months . Principal investigator : Stephen Hohmann , MD .
INTERHEART EX – This study evaluates the extension of the diagnostic and therapeutic applications of microarrays in heart transplantation , a multi-center study . Principal investigator : Shelley Hall , MD .
INTERMACS – The Intermacs registry is a national quality improvement system designed to advance the understanding and application of mechanical circulatory support in order to improve the duration and quality of life in patients with advanced heart failure . Principal investigator : Dan M . Meyer , MD .
IONIS NEURO-TRANSFORM – A phase 3 global , openlabel , randomized study to evaluate the efficacy and safety of ION-682884 in patients with hereditary transthyretin-mediated amyloid polyneuropathy . Principal investigator : Parag Kale , MD .
LONGTERM LMCA – A study that evaluates the long term safety and efficacy of percutaneous coronary artery intervention for unprotected left main coronary artery disease : the BHVH experience . Principal investigator : James Choi , MD .
LOW-RISK BICUSPID VALVE TRIAL - Transcatheter aortic valve replacement ( TAVR ) with Medtronic Surgical Aortic Valve Replacement ( SAVR ). The study ’ s objective is to evaluate the procedural safety and efficacy of the Medtronic TAVR system in patients with bicuspid aortic anatomy and severe aortic stenosis at low risk for SAVR . Principal investigator : Robert Stoler , MD .