CLINICAL TRIALS and studies
MEASURING INNOVATION IN HEART AND VASCULAR CARE
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ADAPTABLE – Aspirin Dosing : A Patient-Centric Trial Assessing Benefits and Long-term Effectiveness . Primary Investigator : Peter McCullough , MD
Absorb™ BVS – Randomized controlled trial , a clinical evaluation of Absorb™ BVS , the Everolimus Eluting Bioresorbable Vascular Scaffold in the treatment of subjects with De Novo native coronary artery lesions . Primary Investigator : James W . Choi , MD
Allomap – Outcomes AlloMap Registry ( OAR ) study and sub study : Utility of Donor-Derived Cell-free DNA in Association with Gene-Expression Profiling ( AlloMap ) in Heart Transplant Recipients ( D-OAR ). Primary Investigator : Shelley Hall , MD
Alnylam – Expanded Access Protocol of Patisiran for Patients with Hereditary Transthyretin- Mediated Amyloidosis ( hATTR Amyloidosis ) With Polyneuropathy . Primary Investigator : Parag Kale , MD
Alternative to Curative Ablation – Efficacy , safety and durability of response to dofetilide in patients with atrial fibrillation : alternative to curative ablation . Primary Investigator : Peter Wells , MD
Angiographic Patterns of Myxoma – Primary Investigator : Carlos E . Velasco , MD
Angiography vs Angiography with IVUS – A prospective randomized feasibility trial comparing angiography and angiography with IVUS for treatment of hemodialysis access failures . Primary Investigator : William Shutze , MD
Aortic Valve Replacement – Aortic Valve Replacement for Low Gradient Aortic Stenosis . Primary Investigator : William Roberts , MD
ASAP-TOO – Study of left atrial appendage device , WATCHMAN™ , in patients who cannot take oral coagulants . Primary Investigator : James Choi , MD
ATS Post Approval ( 3f PAS ). Primary Investigator : Robert F . Hebeler , Jr ., MD
AV Node Reentry Tachycardia – Left Septal Slow Pathway Ablation in Patients with AV Node Reentry Tachycardia . Primary Investigator : Peter Wells , MD
Baylor Extracorporeal Membrane Oxygenation Research Program . Primary Investigator : Brian Lima , MD . Sub-investigator : Robert F . Hebeler , Jr ., MD
Baylor Hypertrophic Cardiomyopathy Program Development Project – Time-resolved , 3D phase contrast magnetic resonance imaging ( MRI ) ( 4D Flow ) and Advanced Strain Rate Echocardiography in Patients with Hypertrophic Cardiomyopathy . Primary Investigator : Peter A . McCullough , MD
BioFlow-V ; BIOTRONIK – A prospective randomized multicenter 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 . Primary Investigator : James Choi , MD
Blood Biomarkers for Patients with Chronic Heart Failure – Assessment of multiple blood biomarkers in the personalized management of chronic heart failure . Primary Investigator : Peter A . McCullough , MD
Bio-electrical Impedance Spectroscopy in Heart Transplantation . Primary Investigator : Brian Lima , MD
Burden of Cardiovascular Events following Percutaneous Coronary Intervention . Primary Investigator : Anupama Vasudevan , MD
Cardiac Adiposity – Massive cardiac adiposity at necropsy . Primary Investigator : William Roberts , MD
CardioMEMS – The Impact of using CardioMEMS for Heart Failure ( HF ) Patients in a Large Health Care System : A Registry . Primary Investigator : Shelley Hall , MD
CLINICAL TRIALS AND STUDIES ( FY17 )
Causes of bioprosthetic and mechanical prosthetic dysfunction in the mitral and aortic valve positions . Primary Investigator : William Roberts , MD
Causes of death in patients studied at necropsy at BUMC , 2013-2015 . Primary Investigator : William Roberts , MD
CLEAR Study ( CDA completed ) – A randomized , double-blind , placebo-controlled study to assess the effects of Bempedoic Acid ( ETC-1002 ) on the occurrence of major cardiovascular events in patients with , or at high risk for , cardiovascular disease who are statin intolerant . Primary Investigator : Cara East , MD .
COAPT / COAPT Continued Access Study – A Continued Clinical Evaluation of the Safety and Effectiveness of the MitraClip ® NT System for the Treatment of Functional Mitral Regurgitation in Symptomatic Heart Failure Subjects . The purpose of this Study is to continue the evaluation of the performance of the investigational MitraClip ® NT System in patients with moderate-to-severe or severe functional mitral regurgitation who are not an appropriate candidate for mitral valve surgery . Primary Investigators : Paul Grayburn , MD , Robert F . Hebeler , Jr ., MD
Commonalities of cardiac rupture – Left ventricular free wall , ventricular septum , or papillary muscle during acute myocardial infarction secondary to atherosclerotic coronary artery disease . Primary Investigator : William Roberts , MD
Contribution of Chronic Kidney Disease and Acute Kidney Injury to Heart Failure Outcomes . Primary Investigator , Kristen Tecson , PhD
CUP – Alirocumab Expanded Access Program for the Treatment of Patients with Severe Hypercholestolemia not controlled with maximal tolerated dose of lipidlowering therapy administered according to standard of care . Primary Investigators : Cara East , MD , Peter A . McCullough , MD
CV Surgery Data Outcomes Collection . Primary Investigator : Gonzalo Gonzalez-Stawinski , MD
Determinants of Conduction System Abnormalities and the Need for Permanent Pacing after Transcatheter Aortic Valve Replacement . Primary Investigator : Timothy Ball , MD
Diet Pattern in Women at High Cardiometabolic Risk and CVD – The association between diet pattern among women at high cardiometabolic risk and cardiovascular disease ( CVD ) incidence and mortality rate . Primary Investigators : Hyun Shin , MD , Peter A . McCullough , MD
DREAM – A Double-Blind , Randomized , Sham- Procedure-Controlled , Parallel-Group Efficacy and Safety Study of Allogeneic Mesenchymal Precursor Cells ( rexlemestrocel-L ) in Patients With Chronic Heart Failure Due to Left Ventricular Systolic Dysfunction of Either Ischemic or Nonischemic Etiology : DREAM HF-1 . Primary Investigator : Cara East , MD
Echo Image Quality – Improving the quality of echocardiographic imaging measurements in the diagnosis of severe aortic stenosis . Primary Investigator : Paul Grayburn , MD
Effect of Post-Diabetic Diet Pattern on Mortality . The Effect of Post-Diabetic Diet Pattern on Mortality Among Type 2 Diabetic Women in Nurses ’ Health Study ( NHS ) – Priori Dietary Pattern ( Dietary Quality Score ) Methods ( Project # 1 ) and Posteriori Dietary Pattern Methods ( Project # 2 ). Primary Investigator : Hyun Shin , MD , Peter A . McCullough , MD
Electrocardiographic total 12-lead QRS voltage in patients having operative resection of syphilitic aortic aneurysm . Primary Investigator : William Roberts , MD
EMPEROR-Preserved – A Phase III randomized , double-blind trial to evaluate efficacy and safety of once daily empagliflozin 10mg compared to placebo , in patients with chronic Heart Failure with preserved Ejection Fraction ( HFpEF ). EMPagliflozin outcomE tRial in patients with chrOnic heaRt failure ( EMPEROR-Preserved ) Primary Investigators : Cara East , MD , Peter A . McCullough , MD
EMPEROR-Reduced – A phase III randomized , doubleblind trial to evaluate efficacy and safety of once daily empagliflozin 10mg compared to placebo , in patients with chronic Heart Failure with reduced Ejection Fraction ( HFrEF ). EMPagliflozin outcomE tRial in patients with chrOnic heaRt failure ( EMPEROR- Reduced ) Primary Investigator : Cara East , MD , Peter A . McCullough , MD
Evaluation of XIENCE PRIME™ or XIENCE V ® versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization . Primary Investigator : James W . Choi , MD
EVEREST II / Realism Study – A Study of the Evalve Cardiovascular Valve Repair System ( CVRS ) Endovascular Valve Edge-to-Edge Repair . Primary Investigators : Paul Grayburn , MD , Robert F . Hebeler , Jr ., MD
EVOLVE Short DAPT – A prospective , multicenter , single-arm study designed to assess the safety of 3-month dual antiplatelet therapy ( DAPT ) in subjects at high risk for bleeding undergoing percutaneous intervention . Primary Investigator : Robert Stoler , MD
Excised circular “ cores ” of left ventricular wall – Usefulness of gross and histologic examination of excised circular “ cores ” of left ventricular wall for diagnostic purposes . Primary Investigator : William Roberts , MD
EXCLUDER – Evaluation of the GORE EXCLUDER Iliac Branch Endoprosthesis for the Treatment of Common Iliac Artery Aneurysms or Aorto-Iliac Aneurysms . Primary Investigator : William Shutze , MD
Experience with Endovascular Aortic Repairs at BUMC . Primary Investigator : William Shutze , MD
Extended Release Exenatide vs . Placebo – A Prospective , double blind , placebo controlled , parallel group , randomized trial of extended release exenatide versus placebo in diabetic patients with type 4 cardiorenal syndrome . Primary Investigator : Peter A . McCullough , MD
Facilitating Patient Reported Outcome Measurement for Key Conditions . Primary Investigator : Peter McCullough , MD
Forxiga – Study to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients with Chronic Heart Failure with Reduced Ejection Fraction . Primary Investigator : Susan Joseph , MD
GALACTIC-HF – A Double-blind , Randomized , Placebo-controlled , Multicenter Study to Assess the Efficacy and Safety of Omecamtiv Mecarbil on Mortality and Morbidity in Subjects With Chronic Heart Failure With Reduced Ejection Fraction . Principal Investigator : Susan Joseph , MD
GORE Hybrid Vascular Graft – Evaluation of antiplatelet factor 4 / heparin antibodies in hemodialysis patients implanted with the GORE Hybrid Vascular Graft versus non-heparin bonded synthetic vascular grafts . Primary Investigator : Stephen Hohmann , MD
GREAT – Global Registry for Endovascular Aortic Treatment . Primary Investigator : Dennis Gable , MD
Gross and histological features of mitral valve prolapse . Primary Investigator : William Roberts , MD
HeartWare ® Ventricular Assist System ( VAS ) – Prospective , randomized , controlled , un-blinded , multi-center clinical trial to evaluate the HeartWare ® Ventricular Assist System ( VAS ) for Destination Therapy of advanced heart failure . Primary Investigator : Gonzalo Gonzalez-Stawinski , MD