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CLINICAL TRIALS AND RESEARCH
PROTECTED TAVR - This is a prospective , postmarket , multi-center randomized controlled trial evaluating use of the Sentinel Cerebral Protection System in subjects with aortic valve stenosis who are treated with a commercially available TAVR device . Principal investigator : Robert Stoler , MD .
QUEST - The primary study objective is to evaluate the safety and effectiveness of the Altius ® System High Frequency Nerve Block ( HFNB ) treatment for the management of post amputation pain . The secondary study objective is to determine the impact of Altius HFNB treatment for post amputation pain on health outcomes , including measurement health related quality of life and use of pain medications . Principal investigator : John F . Eidt , MD .
RAPAD - The objective of this study is to determine if the novel use of a commercially-available radiation protection pad will significantly reduce the radiation exposure to the operating surgeon during fluoroscopic-imaging guided procedures . Principal investigator : Gregory Pearl , 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 : Cesar Guerrero-Miranda , MD .
REPRISE III - The objective of this study is to evaluate the safety and effectiveness of the Lotus™ Valve System and LOTUS Edge™ Valve System for transcatheter aortic valve replacement ( TAVR ) in symptomatic subjects with calcific , severe native aortic stenosis who are considered at extreme or high risk for surgical valve replacement . Principal investigator : Robert Stoler , MD .
RNA SEQUENCING SARCOIDOSIS - Comprehensive identification of molecular biomarkers for cardiac sarcoidosis from whole blood using next generation RNA sequencing . Principal investigator : Detlef Wencker , MD .
SHOCKWAVE – A prospective , multi-center , singlearm , global IDE study of the Shockwave Coronary Intravascular Lithotripsy System with the Shockwave C2 Coronary IVL Catheter in calcified coronary arteries ( Disrupt CAD III Study ). Principal investigator : Robert Stoler , MD .
SHORE - This is an observational registry to assess the clinical utility of surveillance using HeartCare testing services , in association with clinical care of heart transplant recipients . Principal investigator : Shelley Hall , MD .
SLEEP APNEA POST CARDIAC TRANSPLANT – This study evaluates the impact of sleep apnea post cardiac transplantation . Principal investigator : Sandra Carey , PhD .
SMART - Small Annuli Randomized to Evolut or Sapien Trial . Principal investigator : Robert Stoler , MD .
SOLVE CRT - Safety & Effectiveness of WISE CRT System : Stimulation Of the Left Ventricular Endocardium for Cardiac Resynchronization Therapy in non-responders , previously untreatable and highrisk upgrade patients . Principal investigator ( all area sites including Dallas ): Steven Kindsvater , MD . Lead investigator Dallas site : Robert Gottlieb , MD , PhD .
SPIRRIT HFpEF – A unique registry-randomized clinical trial ( RRCT ) that will test the hypothesis that spironolactone plus standard of care compared to standard of care alone reduces the composite of cardiovascular mortality and heart failure hospitalization . Principal investigator : Timothy Gong , MD .
SUMMIT - Clinical trial to evaluate the safety and effectiveness of using the Tendyne Mitral Valve System for the treatment of symptomatic mitral regurgitation . Principal investigator : Robert F . Hebeler , Jr ., MD .
SURTAVI – This study is designed to investigate the safety and efficacy of transcatheter aortic valve implantation in patients with severe , symptomatic aortic stenosis at intermediate surgical risk by randomizing patients to either surgical aortic valve replacement or transcatheter aortic valve replacement . Principal investigator : Robert Stoler , MD .
TARGET - The TRAGET-IV NA trial is a multi-center randomzed assessment of the Firehawk rapamycin TARGET eluting cobalt chromium coronary stent system . North American Trial . Principal investigator : James Choi , MD .
TOPCAT – A study of the retrospective use of public-use data made available by NIH . Principal investigator : Peter McCullough , MD .