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QUEST – Electrical Nerve Block for Amputation Pain : The purpose of this clinical trial is to learn whether electrical nerve block via the Altius System is a safe and effective treatment for patients with phantom limb pain and / or residual limb pain . Principal investigator : John F . Eidt , MD .
REDUCE LAP-HF – The study evaluates the Corvia Medical , Inc . IASD ® System II to reduce elevated left atrial pressure in patients with heart failure . The Corvia Medical InterAtrial Shunt Device ( IASD ® ) System II is indicated for the improvement in quality of life and reduction of heart failure related symptoms and events in patients with heart failure with preserved ( HFpEF ) or mid-range ejection fraction ( HFmrEF ) with elevated left atrial pressures , who remain symptomatic despite standard GDMT . Principal investigator : Susan Joseph , MD .
SHEARWAVE – This trial determines the association of liver stiffness with development of post-LVAD RHF and identifies cutpoint ( s ) of LS associated with increased mortality during hospital stay , at 30 days , and at 1 year . The trial also determines the association between LS and post-LVAD complications including the development of cardiorenal syndrome . Principal investigator : Amarinder Bindra , MD .
SOLVE CRT - This study is a prospective , multicenter , randomized , controlled , double-blinded , pivotal trial to study the safety and efficacy of the WiSE-CRT System for Cardiac Re-synchronization Therapy . Lead investigator for Dallas site : Manish Assar , MD .
SOPRANO – This study evaluates the effect of macitentan 10 mg on pulmonary vascular resistance ( PVR ) as compared to placebo in subjects with pulmonary hypertension ( PH ) after left ventricular assist device implantation . The study also evaluates the effect of macitentan 10 mg as compared to placebo on cardio-pulmonary hemodynamics and disease severity in subjects with PH after LVAD implantation . Finally , the study explores the potential effect of macitentan 10 mg as compared to placebo on right ventricular function , selected clinical events , and on renal function as measured by glomerular filtration rate ( GFR ), in subjects with PH after LVAD implantation . Principal investigator : Shelley Hall , MD .
SPIRRIT – Spironolactone Initiation Registry Randomized Interventional Trial in Heart Failure With Preserved Ejection Fraction ( SPIRRIT ). The study evaluates heart failure patients with preserved ejection fraction ( HFPEF ) in the Swedish Heart Failure Registry ( 2550 patients ) and HFPEF patients in US ( 650 patients ). HFPEF is defined as symptoms / signs of heart failure ( HF ), elevated NTproBNP ( B-type Natriuretic Peptide ; N-terminal pro b-type
Natriuretic Peptide ) and EF >= 40 %. Principal investigator : Timothy Gong , MD .
STOP PERSISTENT AF – The STOP Persistent AF trial evaluates the safety and efficacy of a dry-balloon device in those with recurrent , symptomatic atrial fibrillation ( AFib ) that has not been controlled by medication . Co-principal investigators : Peter Wells , MD ; Kevin Wheelan , MD .
SUMMIT – Clinical trial to evaluate the safety and effectiveness of using the Tendyne Mitral Valve System for the treatment of symptomatic mitral regurgitation ( SUMMIT ). Principal investigator : Paul Grayburn , MD .
TRANSFORM-HF – A large-scale , pragmatic , randomized , unblinded clinical effectiveness study comparing torsemide versus furosemide as treatment for heart failure . Principal investigator : Melody Sherwood , MD .
TRILUMINATE – A randomized , controlled trial to demonstrate the safety and effectiveness of the TriClip device in improving clinical outcomes in symptomatic patients with severe tricuspid regurgitation ( TR ), who are at intermediate or greater estimated risk for mortality with tricuspid valve surgery . The study compares the TriClip device to control medical therapy . Principal investigator : James Choi , MD .
VELOXIS – A Phase II study evaluating the efficacy of tacrolimus extended release tablets to twice daily tacrolimus dosing regimen . Twenty-five adult recipients of a heart transplant will be enrolled in each group – one receiving a once a day dosing of Envarsus , the other receiving twice a day dosing of Prograf . Results of the two groups will be compared and evaluated for short term safety and tolerability of Envarsus . Principal investigator : Shelley Hall , MD .
FORT WORTH FY20 CLINICAL TRIALS AND STUDIES
AMPLATZER™ AMULET™ LAA OCCLUDER TRIAL – ( AMULET IDE ) is designed to evaluate the safety and effectiveness of the AMPLATZER Amulet Left Atrial Appendage Occluder . Study participants are randomized in a 1:1 ratio between the Amulet LAA occlusion device ( treatment ) or the WATCHMAN ® LAA closure device ( control ). Principal investigator : Craig Delaughter , MD .
MORE – An Abbott study of the impact of Multi-Point Pacing in the treatment of patients not responding to standard cardiac resynchronization therapy ( CRT ). Principal investigator : Syed Shah , MD ; Subinvestigator : Craig Delaughter , MD .
Baylor Scott & White Heart and Vascular Hospital Research and Clinical Trials