Colorado Heart and Vascular is dedicated to participating in ongoing clinical research, in order to continue to advance the field of cardiovascular medicine and offer the newest therapies to our patients.
Below is the list of trials for which we are currently enrolling. For any questions, please contact David Bailey in the Research Department at 303-595-2619 or send an email to research@chvpc.com.
OPTION (Boston Scientific):
The primary objective of this study is to determine if left atrial appendage closure with the WATCHMAN FLX Device is a reasonable alternative to oral anticoagulation following percutaneous catheter ablation for high risk patients with non-valvular atrial fibrillation.
Principle Investigator: Dr. Ganesh Venkataraman
Easy PVI (University of Arizona in partnership with Medtronic, Inc.):
The objective of this randomized multicenter study is to evaluate the safety, feasibility and potential benefits of routine same day discharge after cryoballon (CB) ablation with the second generation CB. With this new technology, Colorado Heart & Vascular and St. Anthony’s Hospital hope to reduce overall costs and improve patient satisfaction.
Principle Investigator: Dr. Ganesh Venkataraman
ECLIPSE (Cardiovascular Systems, Inc.):
ECLIPSE is a prospective, randomized one to one (1:1), multi-center trial designed to evaluate vessel preparation with the Diamondback 360® Coronary Orbital Atherectomy System (OAS) Classic Crown compared to conventional balloon angioplasty technique prior to stent implantation for the treatment of severely calcified coronary artery lesions.
Principle Investigator: Dr John Altman
Product Surveillance Registry (Medtronic, Inc.):
The purpose of the Registry is to provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products. The Registry data is intended to benefit and support interests of patients, hospitals, clinicians, regulatory bodies, payers, and industry by streamlining the clinical surveillance process and facilitating leading edge performance assessment via the least burdensome approach.
Principle Investigator: Dr. Ganesh Venkataraman
Humanitarian Use Device-Cardiology-GRAFTMASTER® RX Coronary Stent (Abbott Laboratories):
The purpose of this study is to research the efficacy of the FDA approved GRAFTMASTER® RX Coronary Stent Graft System for commercial use in selected patients under a Humanitarian Device Exemption (HDE).
National Cardiogenic Shock Initiative (Henry Ford Institute)
This study evaluates the use of early mechanical circulatory support in patients presenting with acute myocardial infarction and cardiogenic shock. Patients are treated according to the National Cardiogenic Shock Initiative protocol, which emphasizes early identification of cardiogenic shock and rapid delivery of mechanical circulatory support based on invasive hemodynamics. All patients treated in this manner are enrolled in the National Cardiogenic Shock registry.
Principle Investigator: Dr Nima Aghili
STEMI-DUT
The purpose of the study is to demonstrate the safety and effectiveness of primary Left Ventricular unloading and a thirty-minutes delay to reperfusion vs. current standard of care in reducing infarct size and heart failure-related clinical events in patients presenting with anterior ST-Elevation Myocardial Infarction. The Objective is to demonstrate that primary Left Ventricular unloading and a thirty-minute delay-to-reperfusion, when compared to the control cohort, treated according to the current standard-of-care treatment of Anterior STEMI, has the following effects:
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Reduction in Infarct Size
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Reduction in the Incidence of Heart Failure-related clinical events
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An acceptable safety profile
Principle Investigator: Dr Nima Aghili
Sub Investigator: Dr John Altman, Dr Abdullah Bitar, Dr David Halpin