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Cardiology

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Longitudinal Surveillance Study of the 4-SITE Lead/Header System
8/22/2014
Mark Hamer, MD

For patients who will receive, or currently have, an FDA approved Boston Scientific 4-SITE lead and pulse generator with a 4-SITE header...

Absorb Randomized Controlled Trial – A Clinical Evaluation of Absorb Everolimus Eluting Bioresorbable Vascular Scaffold vs. Xience Drug Eluting Metal Stent in the Treatment of Subjects with de novo Native Coronary Artery Lesions
8/22/2014
Thomas Stuver, MD

Compare treatment of lesions (narrowing) in the coronary arteries using bioresorbable stents versus metallic drug-eluting stents. Sponsor: Abbott...

Absorb IV is a prospective, randomized (1:1, Absorb Bioresorbable Ventricular Scaffold (BVS) to XIENCE), single-blind, multi-center study
8/22/2014
Thomas Stuver, MD

Compare treatment of lesions (narrowing) in the coronary arteries using bioresorbable stents versus metallic drug-eluting stents. Absorb IV is a...

A randomized, double-blind, placebo-controlled, event-driven trial of quarterly subcutaneous canakinumab in the prevention of recurrent cardiovascular events among stable post-myocardial infarction patients with elevated hsCRP.
8/22/2014
Thomas Stuver, MD

Study of post-myocardial infarction (heart attack) drug to prevent future cardiovascular events using interleukin anti-body to reduce...

CAPTIVATE: CAPTure Information Via Automatic Threshold Evaluation; a Prospective, Non-Randomized, Multi-Center, IDE Clinical Study
8/22/2014
Thomas Stuver, MD

This study will evaluate the PaceSafe Right Ventricular Autothreshold (RVAT) and Left Ventricular Autothreshold (LVAT) features for patients...

Prospective, Non-Randomized Clinical Study to Establish the Safety, Performance and Effectiveness of the Ingevity Active and Passive Fixation Pace/Sense Leads
8/22/2014
Mark Hamer, MD

Clinical trial to establish the safety and effectiveness of a new Pacemaker lead called Ingevity. Sponsor: Boston Scientific.

A Randomized, Open-Label, Multi-Center, Active-Controlled, Parellel Group Study to Determine the Efficacy and Safety of the REG-1 Anti-Coagulation System Compared to Bivalirudin in Subjects Undergoing Percutaneous Coronary Intervention
8/22/2014
Thomas Stuver, MD

To compare a non-reversible anticoagulant (Bival) with a reversible anti-coagulant system, featuring an anti-coagulant study drug and its reversal...

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 2.25 mm to 4.2 mm
Thomas Stuver, MD

The objective of the study is to assess the safety and effectiveness of the Resolute Zotarolimus-Eluting Coronary Stent System for the treatment of...

Clinical Trial of the SonRtip Lead and Automatic AV-VV Optimization Algorithm in the PARADYM RF SonR CRT-D
8/22/2014
Parag Patel, MD

A multi-center, prospective, randomized, double-blind study to assess the safety and effectiveness of the automatic optimization algorithm as...