59 and mortality in high risk patients following an acute myocardial infarction . Principal investigator : Kyle Bass , MD .
PROACT – A multicenter , longitudinal , randomized ( randomization to occur at the 3-month followup ) study comparing the On-X valve on low dose anticoagulation ( test group ) to concomitant control groups of On-X valves receiving standard Coumadin / aspirin therapy , and also to FDA objective performance criteria ( OPC ) for heart valve replacement . Principal investigator : Robert Smith , MD ; Sub-investigators : Cara East , MD ; Robert F . Hebeler , Jr ., MD .
QRK309 – A randomized , double-blind , placebo controlled , Phase II study to evaluate the efficacy and safety of QPI-1002 for the prevention of acute kidney injury in subjects at high risk for AKI following cardiac surgery . Principal investigator : Robert F . Hebeler , MD .
SPYRAL OFF MED – Global clinical study of renal denervation with the symplicity spyral multielectrode renal denervation system in patients with uncontrolled hypertension in the absence of antihypertensive medications : SPYRAL Study . Principal investigators : James W . Choi , MD ; Cara East , MD .
SPYRAL ON MED – Global clinical study of renal denervation with the symplicity spyral multielectrode renal denervation system in patients with uncontrolled hypertension on standard medical therapy . Principal investigators : James W . Choi , MD ; Cara East , MD .
SPYRAL DYSTAL - Global clinical study of renal denervation in the distal main and first order branch renal arteries using the Symplicity Spyral multi-electrode renal denervation system : Principal investigators : James W . Choi , MD ; Cara East , MD .
VESALIUS – A double-blind , randomized , placebocontrolled , multicenter study to evaluate the impact of evolocumab on major cardiovascular events in patients at high cardiovascular risk without prior myocardial infarction or stroke - VESALIUS Study . Principal investigator : Cara East , MD .
ADDITIONAL FY20 DALLAS SITE CLINICAL TRIALS
ACURATE – This trial compares the ACURATE transfemoral aortic valve system with other commercially available valves that can be delivered without open heart surgery . Principal investigator : Robert Stoler , MD .
APOLLO – A multicenter , 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 multicenter 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 – A Phase III , multinational , 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 .
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 WATCHMAN 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 .
BIOELECTRICAL IMPEDANCE SPECTROSCOPY IN HEART TRANSPLANTATION – A prospective cohort study that evaluates the use of bio-electrical impedance spectroscopy ( BIS ) as a measure of body composition and assess the associations with surgical outcomes . Principal investigator : Jeanette Hasse , PhD .
BIOFLOW – A prospective , multicenter , single-arm study to evaluate participants with coronary artery disease who undergo an on-label percutaneous coronary intervention with a placed Orsiro stent within the prior 24 hours and who will be screened post-index procedure per the protocol inclusion and exclusion criteria . Following the index procedure and study enrollment , subjects will be followed for five years . Principal investigator : Robert Stoler , 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 .
Baylor Scott & White Heart and Vascular Hospital Research and Clinical Trials