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CLINICAL TRIALS AND RESEARCH
ALLOSURE EXERCISE – This study uses AlloSure test characteristics in immunologically quiescent and immunologically active heart transplant recipients . Assessing maximal cardiopulmonary stress testing prior to assay and the preservation of test specificity while enhancing sensitivity . Principal investigator : Robert Gottlieb , MD , PhD .
APOLLO - A multi-center , global , prospective , randomized , interventional pre-market study to evaluate whether TMVR is non-inferior to conventional mitral valve surgery at one year for patients with severe symptomatic native mitral regurgitation . Study subjects are randomized on a 1:1 basis to either TMVR with the Medtronic Intrepid™ TMVR System or to conventional mitral valve surgery to compare treatment efficacy . Principal investigator : Ravi Vallabhan , MD .
APOLLO-B - Randomized , double-blind , placebocontrolled multi-center study to evaluate the efficacy and safety of patisiran in patients with transthyretin amyloidosis with cardiomyopathy ( ATTR Amyloidosis with cardiomyopathy ). Principal investigator : Parag Kale , MD .
ARRAY-797-301 - A phase 3 , multi-national , randomized , placebo-controlled study of ARRY- 371797 in patients with symptomatic dilated cardiomyopathy due to a Lamin A / C gene mutation . The study also evaluates the effect of ARRY-371797 on functional capacity ( as measured by the 6-minute walk test ( 6MWT ) compared to placebo in NYHA Class II-IV patients . Principal investigator : Robert Gottlieb , MD , PhD .
ARIES HM3 - Prospective , randomized , doubleblinded , placebo-controlled clinical investigation of advanced heart failure patients treated with the HM3 with two different antithrombotic regimens : vitamin K antagonist with aspirin versus vitamin K antagonist with placebo . Principal investigator : Shelley Hall , MD .
ASAP-TOO - Assessment of the WATCHMAN™ device in patients unsuitable for oral anticoagulation . The purpose of this study is to establish the safety and effectiveness of the left atrial appendage closure device for subjects with non-valvular atrial fibrillation who are not suitable for oral anticoagulation therapy . Principal investigator : James Choi , MD .
BARIATRIC SURGERY ON CARDIOVASCULAR FUNCTION - The purpose of this study is to collect data from patients with advanced heart failure undergoing bariatric surgery to investigate the short-term and long-term outcomes of weight loss surgery on patients with heart failure . Principal investigator : Daniel Davis , DO .
BIOFLOW V – A prospective randomized multi-center study to assess the safety and effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in the treatment of subjects with up to three de novo or restenotic coronary artery lesions – V . Principal investigator : James Choi , MD .
BIOFLOW VII - The purpose of this post-approval study is to confirm that the clinical performance of the Orsiro ® stent in a real-world setting is similar to the clinical performance observed for Orsiro in the BIOFLOW-V Investigational Device Exemption pivotal trial . Principal investigator : Robert Stoler , MD .
BIS – Bioelectrical Impedance Spectroscopy in Heart Transplantation . This study tracks post-transplant changes in body composition and correlation with conventional preoperative risk assessment modalities . Principal investigator : Jeannette Hasse , PhD .
BREATHE - A study to assess the efficacy and safety of Gimsilumab in subjects with lung injury or acute respiratory distress syndrome secondary to COVID-19 . Gimsilumab is a monoclonal antibody against granulocyte macrophage-colony stimulating factor ( GM-CSF ), which is a myeloid cell growth factor and pro-inflammatory cytokine . Late stages of COVID-19 can be marked by a “ cytokine storm ” and the overactivation of inflammatory myeloid cells that infiltrate and damage tissue , such as the lungs . Inhibition of GM-CSF may be able to reverse this pathology . This multi-center , adaptive , randomized , double-blind , placebo-controlled study assessed the efficacy and safety of gimsilumab in subjects with lung injury or acute respiratory distress syndrome ( ARDS ) secondary to COVID-19 . Baylor Dallas was a leading enroller nationwide for this study . Principal investigator : Robert Gottlieb , MD , PhD .
CARDIOMEMS – This study evaluates the impact of using CardioMEMS for heart failure ( HF ) patients in a large healthcare system : a registry . Principal investigator : Shelley Hall , MD .
CARMAT TOTAL ARTIFICIAL HEART - Evaluate the safety and performance of the Carmat Total Artificial Heart in subjects with advanced heart failure requiring biventricular support . Baylor University Medical Center is one of seven sites participating in this bridge-to-transplant study for advanced heart failure patients . Principal investigator : Dan Meyer , MD .
CL005 – Safety and parameters at which UPT terminates VT and VF . Principal investigator : Praveen Rao , MD .