Outcomes 2016 - Baylor Hamilton Heart and Vascular Hospital FY 2016 | Page 72

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
REAFFIRM – Randomized Evaluation of Atrial
Fibrillation Treatment with Focal Impulse and Rotor
Modulation Guided Procedures. Primary Investigator:
Robert Kowal, 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
REPRISE III: Repositionable Percutaneous
Replacement of Stenotic Aortic Valve through
Implantation of Lotus™ Valve System – Randomized
Clinical Evaluation. Primary Investigator:
Robert Stoler, MD
Reveal AF – Continuous Monitoring with the Reveal
XT implantable cardiac monitor or newer approved
version the incidence of atrial fibrillation (AF) in
patients suspected to be at high risk for having AF.
Primary Investigator: Melissa Carry, MD
Safety of High-Intensity Resistance Training
in a Cardiac Rehabilitation Program. Primary
Investigator: Jenny Adams, PhD
Slow Gait Speed – Predictive Value of Slow Gait
Speed for Auguring Post-Operative Outcomes after
Implantation of Durable Mechanical Circulatory
Support Devices as Destination Therapy in Advanced
Chronic Systolic Heart Failure. Primary Investigator:
Jose Mendez, 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
SPIRE 1 Phase 3 and SPIRE 2 Phase 3 – Multi-Center,
Double-Blind, Randomized, Placebo-Controlled,
Parallel Group Evaluation of the Efficacy, Safety, and
Tolerability of Bococizumab (PF 04950615) in Reducing
the Occurrence of Major Cardiovascular Events in
High Risk Subjects (B1481022 Protocol Amendment 1).
Primary Investigator: Peter A. McCullough, 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
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
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SSI Study – Driveline Silicone Skin Interface (SSI)
Registry. Primary Investigator: Shelley Hall, MD
STICH – Surgical Treatment for Ischemic Heart Failure
Trial. Primary Investigator: Paul Grayburn, MD
SURTAVI – Medtronic Surgical Replacement and
Transcatheter Aortic Valve Implantation: SURTAVI.
Primary Investigator: Robert Stoler, MD
Symplicity AF. Primary Investigator:
Robert Kowal, MD
SYMPLICITY HTN-3 – Renal Denervation in
Patients with Uncontrolled Hypertension:
SYMPLICITY HTN- 3. Primary Investigators:
James W. Choi, MD, Cara East, MD
Umbrella Protocol – Studies Utilizing Data from
Baylor Cardiovascular Databases. Primary Investigator:
Anupama Vasudevan, MD
USPella – A Multi-Center, Data Registry Study
designed to collect data from subjects that have been
treated using the IMPELLA 2.5 circulatory device per
institution’s standard of care. Primary Investigator:
Robert Stoler, MD
Validation of PICC derived Fick cardiac output in
patients with heart failure. Primary Investigator:
Parag Kale, MD
VEST – The Vest Prevention of Early Sudden Death
Trial (VEST). Primary Investigator: Jay Franklin, MD
SYNCARDIA – 50cc TAH-t for Bridge to Transplant.
Primary Investigator: Gonzalo Gonzalez-Stawinski, MD VOYAGER – An international, multicenter,
randomized, double-blind, placebo-controlled phase 3
trial investigating the efficacy and safety of rivaroxaban
to reduce the risk of major thrombotic vascular
events in patients with symptomatic peripheral artery
disease undergoing lower extremity revascularization
procedures. Primary Investigator: William Shutze, MD
Takotsubo Cardiomyopathy Registry. Primary
Investigator: Jeffrey M. Schussler, MD Women’s Experiences during an Acute Myocardial
Infarction. Primary Investigator: Dena Allen
TAXUS Liberte Paclitaxel-Eluting Coronary Stent
System – A U.S. post-approval study of the TAXUS
Liberte Paclitaxel-Eluting Coronary Stent System.
Primary Investigator: Robert Stoler, MD World-wide Randomized Antibiotic Envelope
Infection Prevention Trial. Primary Investigator:
Jay Franklin, MD
Syphilitic Aortitis – Syphilis as a cause of thoracic
aortic aneurysm. Primary Investigator:
William C. Roberts, MD
TEE Indication and Post Procedure Management –
Indication and Post Procedure Management Changes
of Trans-Esophageal Echocardiography. Primary
Investigator: Jeffrey M. Schussler, MD
Tendyne – Early Feasibility Study of Tendyne
Bioprosthetic Mitral Val ve System Primary Investigator:
Paul A. Grayburn, MD
THRASOS – A Phase II Multi-Center, Parallel-
Group, Randomized, Double Blind, Proof-of-Concept,
Adaptive Study Investigating the Safety and Efficacy
of THR-184 Administered via Intravenous Infusion.
Primary Investigators: Robert F. Hebeler, Jr., MD,
Cara East, MD
TIGRIS – Evaluation of the GORE TIGRIS Vascular
Stent in the Treatment of Atherosclerotic Lesions of the
Superficial Femoral and Proximal Popliteal Arteries.
Primary Investigator: Dennis Gable, MD
Timing of Coronary Angiography and MARCE –
Timing of Coronary Angiography and Multivariate Risk
for Cardiac Surgery Associated Acute Kidney Injury and
Major Adverse Renal and Cardiac Events (MARCE).
Primary Investigator: Peter A. McCullough, MD
Total QRS Voltage in Cardiac Sarcoidosis. Primary
Investigator: William C. Roberts, MD
Transient AV Block with Cryoablation – Clinical
characteristics of Transient AV Block with cryoablation.
Primary Investigator: Peter Wells, MD
Type A Aortic Dissections – Outcomes Following Type A
Aortic Dissections: the Baylor University Medical Center
Experience. Primary Investigator: Brian Lima, MD
Use of the PRIMUS RS to Assess Strength
Outcomes after Specificity of Training in a Cardiac
Rehabilitation Setting. Primary Investigator:
Jenny Adams, PhD
ZENITH – Zenith TX2 TAA Endovascular Graft
Post-Market Approval Study. Primary Investigator:
William Shutze, MD