Outcomes 2017 - Baylor Heart and Vascular Services FY2017 | Page 85

Heart Weight in Autopsy Cases. Primary Investigator: William C. Roberts, MD
HUMANITY – An Assessment of Humacyte’ s Human Acellular Vessel in Patients Needing Renal Replacement Therapy: A Comparison with ePTFE Grafts as Conduits for Hemodialysis. Primary Investigator: Stephen Hohmann, MD
Impact of Troponin Testing Across the Baylor Scott & White NTX Region. Primary Investigator: Robert Kowal, MD
Low-Risk TAVR Patients – Transcatheter Aortic Valve Replacement With the Medtronic Transcatheter Aortic Valve Replacement System In Patients at Low Risk for Surgical Aortic Valve Replacement. Primary Investigators: Robert Stoler, MD, Robert F. Hebeler, Jr. MD
Infrageniculate Peripheral Disease Prospective Trial – Comparing laser atherectomy to angioplasty with / without stenting for infrageniculate peripheral disease. Primary Investigator: William Shutze, MD
Intrepid Twelve Trial – Medtronic’ s trial for severe mitral regurgitation. Primary Investigator: Paul Grayburn, MD
INVESTED – A NIH research to study Influenza Vaccine to Effectively Stop Cardio Thoracic Events and Decompensated heart failure( INVESTED) Primary Investigator: Peter A. McCullough, MD
Mitral Annular Calcium – Mitral valve replacement because of mitral stenosis due to massive mitral annular calcium. Primary Investigator: William Roberts, MD
Mitral Valve Replacement After Failed Mitral Repair – Replacement with ring insertion for pure mitral regurgitation. Primary Investigator: William Roberts, MD
Neurocognitive function in destination therapy patients before and after receiving a continuous flow left ventricular assist device. Primary Investigators: Shelley Hall, MD, Sandra Carey, NP
ODYSSEY OLE – Open-Label Extension Study of EFC12492, R727-CL-1112, EFC12732, & LTS11717 Studies to Assess the Long-Term Safety and Efficacy of Alirocumab in Patients with Heterozygous Familial Hypercholesterolemia. Primary Investigator: Cara East, MD
ODYSSEY OUTCOMES – Randomized, double-blind, placebo-controlled, parallel group study to Evaluate the Effect of SAR236553 / REGN 727 on the occurrence of cardiovascular events in patients who have recently experienced an acute coronary syndrome. Primary Investigator: Cara East, MD
PARADISE – A Multi-Center Randomized, Double- Blind, Active-Controlled Study to Evaluate the Effects of LCZ696; comparing LCZ696 to Ramipril on morbidity and mortality in high risk patients following an acute myocardial infarction. Primary Investigator: Kyle Bass, MD
Pure Aortic Regurgitation – Associated with congenitally malformed bicuspid aortic valve and unassociated with infective endocarditis. Primary Investigator: William Roberts, MD
QUARK – 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. Primary Investigator: Robert F. Hebeler, MD, Sub-investigator: Cara East, MD
Radial Versus Femoral Artery Approach – Clinical outcomes and metabolomic and damage associated molecular patterns of acute kidney injury in patients undergoing percutaneous coronary intervention via the radial versus femoral artery approach. Primary Investigator: Jeffrey M. Schussler, MD
Rationale for a Single Right and Left Atrial Ablation. In patients referred for atrial flutter ablation, the long term occurrence of atrial fibrillation and atypical atrial flutter is higher in those who present to the hospital in sinus rhythm: rationale for a single right and left atrial ablation procedure. Primary Investigator: Peter Wells, MD
RELAX – A multicenter, randomized, double-blind, placebo-controlled phase IIIb study to evaluate the efficacy, safety and tolerability of Serelaxin when added to standard therapy in acute heart failure patients. Primary Investigator: Cara East, MD

CLINICAL TRIALS and studies

ION Paclitaxel-Eluting Platinum Chrominum Coronary Stent System – A U. S. post-approval study. Primary Investigator: Robert Stoler, MD
IXCELL EXTENSION – A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety and Tolerability of Transendocardial Injection of Ixmyelocel-T in Subjects with Heart Failure Due to Ischemia Dilated Cardiomyopathy( IDCM). Primary Investigator: Cara East, MD
JOSTENT – Coronary Stent Graft Humanitarian Use Device. Primary Investigator: Robert Stoler, MD
Levo CTS – A double-blind, randomized placebocontrolled study of Levosimendan in Patients with Left Ventricular Systolic Dysfunction undergoing cardiac surgery requiring cardiopulmonary bypass; LEVO- CTS. Primary Investigator: Daniel Gunn, MD, Subinvestigator: Cara East, MD
Lixisenatide in Type 2 Diabetes – A randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate cardiovascular outcomes during treatment with lixisenatide in type 2 diabetes patients after an acute coronary syndrome event. Primary Investigator: Cara East, MD
LOWER – Lomitapide Observational Worldwide Evaluation Registry. Primary Investigator: Peter A. McCullough, MD
Medtronic CoreValve – Continued Access Study( Extreme Risk Patients) – Evolut R, Expanded Use, U. S. Pivotal Trial. Primary Investigators: Robert Stoler, MD, Robert F. Hebeler, Jr., MD
Medtronic Endeavor ® Resolute Zotarolimus Eluting Coronary Stent System – A clinical evaluation of the Medtronic Endeavor ® Resolute Zotarolimus Eluting Coronary Stent System in the treatment of De Novo lesions in native coronary arteries with a reference vessel diameter of 2.25mm to 4.2mm. Primary Investigator: Robert Stoler, MD
Mental Health of Brief-Stay Cardiac Patients – Assessment of the value of a brief intervention and referral to a mental health professional for briefstay cardiac hospital patients who report feelings of hopelessness and worthlessness. Primary Investigator: Michael Davis, ThM
Mitral and Aortic Valve Replacement Indications and Results – Indications for and results of combined mitral and aortic valve replacement at BUMC. Primary Investigator: William Roberts, MD
PERSPECTIVE – A multi-center, randomized, doubleblind, active-controlled study to evaluate the effects of LCZ696 compared to valsartan on cognitive function in patients with chronic heart failure and preserved ejection fraction. Primary Investigator: Cara East, MD
PIONEER-HF – A multicenter, randomized, doubleblind, double dummy, parallel group, active-controlled 8-week study to evaluate the effect of sacubitril / valsartan( LCZ696) versus enalapril on changes in NT-proBNP and safety and tolerability of in hospital initiation of LCZ696 compared to enalapril in HFrEF patients who have been stabilized following hospitalization for acute decompensated heart failure( ADHF). Principal Investigator: Shelley Hall, MD
PORTICO – A randomized, double-blind, placebocontrolled, prospective, multicenter, parallel group study to assess the safety and efficacy of macitentan in patients with portopulmonary hypertension. Primary Investigator: Cara East, MD
Post-MI Remodeling Prevention Therapy Study. Primary Investigator: Jay Franklin, MD
Pragmatic Trial of Airway Management in Out-of- Hospital Cardiac Arrest( Pragmatic Airway Resuscitation Trial). Primary Investigator: John Garrett, MD
Prasugrel use in patients receiving bivalirudin in the cardiac cath lab. Primary Investigator: Jeffrey M. Schussler, MD
Preventive Cardiology Registry. Primary Investigator: Peter A. McCullough, MD
PRESERVED-HF – PREVENTion of Non-Surgical Bleeding by Management of HeartMate II Patients without Antiplatelet Therapy. Primary Investigator: Susan Joseph, MD
PREVENT II – PREVENTion of Non-Surgical Bleeding by Management of HeartMate II Patients without Antiplatelet Therapy. Primary Investigator: Susan Joseph, MD
PRIME-HF – Predischarge Initiation of Ivabradine in the Management of Heart Failure. Primary Investigator: Shelley Hall, MD
Protocol to conduct a broad range of retrospective data reviews on heart transplants, lung transplants, VAD and cardiology. Primary Investigator: Gonzalo Gonzalez-Stawinski, MD
Pulmonary Vein Reconnection – Pulmonary vein reconnection after cryoballoon pulmonary vein isolation. Primary Investigator: Kevin Wheelan, MD
REPRISE III: Repositionable Percutaneous Replacement of Stenotic Aortic Valve through Implantation of Lotus™ Valve System – Randomized Clinical Evaluation. Primary Investigator: Robert Stoler, MD, Robert F. Hebeler, Jr., MD
SmartShock Research. Primary Investigator: Jay Franklin, MD
SonRtip Lead – Clinical Trial of the SonRtip Lead and Automatic AV-VV Optimization Algorithm in the Paradym RF SonR CRT-D. Primary Investigator: Jay Franklin, MD
SOPRANO – A prospective, multicenter, double-blind, randomized placebo-controlled, parallel-group study to assess the efficacy and safety of macitentan in patients with pulmonary hypertension after left ventricular assist device implantation. Primary Investigator: Shelley Hall, MD
SPYRAL OFF MED – Global Clinical Study of Renal Denervation with the Symplicity Spyral multi-electrode renal denervation system in Patients with uncontrolled Hypertension in the Absence of Antihypertensive medications: SPYRAL Study. Primary Investigator: James W. Choi, MD, Sub-investigator: Cara East, MD
SPYRAL ON MED – Global Clinical Study of Renal Denervation with the Symplicity Spyral multi-electrode renal denervation system in Patients with uncontrolled Hypertension on Standard Medical Therapy. Primary Investigator: James W. Choi, MD, Sub-investigator: Cara East, MD
STICH – Surgical Treatment for Ischemic Heart Failure Trial. Primary Investigator: Paul Grayburn, MD
STOP PERSISTENT AF – Studying the safety and efficacy of the cryoballoon in subjects with persistent AF. Primary Investigator, Peter Wells, MD
SURTAVI – Medtronic Surgical Replacement and Transcatheter Aortic Valve Implantation: SURTAVI. Primary Investigators: Robert Stoler, MD, Robert F. Hebeler, Jr., MD
SYMPLICITY HTN-3 – Renal Denervation in Patients with Uncontrolled Hypertension: SYMPLICITY HTN- 3. Primary Investigator: James W. Choi, MD, Sub-investigator: Cara East, MD
Syphilitic Aortitis – Syphilis as a cause of thoracic aortic aneurysm. Primary Investigator: William Roberts, MD
SYNCARDIA – 50cc TAH-t for Bridge to Transplant. Primary Investigator: Gonzalo Gonzalez-Stawinski, MD
OUTCOMES 2017
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