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Baylor Scott & White Heart and Vascular Hospital Research and Clinical Trials
COREVALVE LOW RISK STUDY – This study evaluates the procedural safety and efficacy of the Medtronic TAVR system on inpatients with bicuspid aortic anatomy and severe aortic stenosis at low risk for SAVR . Principal investigator : Robert Stoler , MD .
CVAD TRIAL – A registry to assess outcomes using a catheter-mounted , LVAD-like device for PCI . Principal investigator : Robert Stoler , MD .
DISRUPT CAD III – A prospective , multicenter , singlearm , global IDE study to evaluate the safety and effectiveness of the Shockwave Coronary IVL System in de novo , calcified , stenotic , coronary arteries prior to stenting . Principal investigator : Robert Stoler , MD .
EARLY TAVR – A prospective , controlled , multicenter study . Patients will be randomized 1:1 to receive either transcatheter aortic valve replacement ( TAVR ) with the Edwards SAPIEN 3 THV or clinical surveillance ( CS ). Patients will be stratified by whether or not they are able to perform a treadmill stress test ; in addition , patients who are screened for enrollment but have a positive stress test will be followed in a registry to collect data on subsequent treatment and mortality , as applicable . Principal investigator : Robert Stoler , MD .
EVOLVE 4.5 / 5.0 – A U . S . post-approval study to prove the safety and effectiveness of the Synergy 4.50 / 5.0 mm Everolimus-Eluting Platinum Chromium Coronary Stent System for treatment of atherosclerotic lesions . Principal investigator : Robert Stoler , MD .
EXCEED – A prospective , single-arm , controlled , multicenter study to establish the safety and effectiveness of the CENTERA THV system in intermediate risk patients who have symptomatic , severe , calcific , aortic stenosis requiring aortic valve replacement . Principal investigator : Robert Stoler , MD .
GALACTIC-HF – This study determines if treatment with omecamtiv mecarbil / AMG 423 when added to standard of care is well tolerated and superior to placebo in reducing the risk of cardiovascular death or heart failure events in subjects with chronic HFrEF . Principal investigator : Susan Joseph , 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 : Shelley Hall , 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 .
HEARTWARE – A prospective , observational , multisite study to provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products . Principal investigator : Dan Meyer , MD .
INTREPID – A study to evaluate the safety and performance of the Twelve Intrepid Transcatheter Mitral Valve Replacement System in high risk patients with severe , symptomatic mitral regurgitation . Principal investigator : Paul Grayburn , MD .
LOW-RISK BICUSPID VALVE TRIAL – 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 .
MOMENTUM 3 CAP – The purpose of this study is to evaluate the safety and effectiveness of the HeartMate III LVAS by demonstrating non-inferiority to the HeartMate II LVAS when used for the treatment of advanced , refractory , left ventricular heart failure . Principal investigator : Shelley Hall , MD .
ONYX – Evaluates the clinical safety and effectiveness of the Resolute Onyx stent in subjects deemed at high risk for bleeding and / or medically unsuitable for more than 1 month DAPT treatment receiving reduced duration ( 1 month ) of DAPT following stent implantation . Principal investigator : James Choi , MD .
PARAGLIDE HF - A multicenter , randomized , double-blind , double-dummy , parallel group , active controlled 8-week study to evaluate the effect of sacubitril / valsartan ( LCZ696 ) versus valsartan on changes in NT-proBNP and safety and tolerability of in-hospital initiation of LCZ696 compared to valsartan in HFpEF patients with acute decompensated heart failure ( ADHF ) who have been stabilized during hospitalization . Principal investigator : Shelley Hall , MD .
QUARK 309 – QPI-1002 Phase III for prevention of Major Adverse Kidney Events ( MAKE ) in subjects at high risk for AKI following cardiac surgery ( QUARK 309 ) – A randomized , double-blind , placebo-controlled , Phase III trial to evaluate QPI- 1002 versus placebo for the prevention of major adverse kidney events in patients at high risk for acute kidney injury following cardiac surgery . Principal investigator : Robert F . Hebeler , MD .