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 our Research Department at 303-595-2619 or research@chvpc.com.
ASAP-TOO (Boston Scientific):
The purpose of this study is to establish the safety and effectiveness of the WATCHMAN™ Left Atrial Appendage Closure (LAAC) Device, including the post-implant medication regimen, for subjects with non-valvular atrial fibrillation who are deemed not to be eligible for anti-coagulation therapy to reduce the risk of stroke. If you are at risk of stroke and have trouble tolerating blood thinners, ask your doctor about the ASAP-TOO clinical trial.
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.
DEFINE PCI (Philips):
The DEFINE PCI study used iFR pullback during coronary intervention procedures to understand the rate and causes of residual ischemia in 500 patients undergoing contemporary PCI. Early results find that residual ischemia (found in nearly 25% of patients) is common, and causes are treatable. Colorado Heart & Vascular was internationally recognized for our heavy participation in this study.
CHAMP Heart Failure Registry (Novartis International AG):
Standard of care guidelines strongly recommend patients with heart failure with reduced ejection fraction (HFrEF) be treated with multiple medications proven to improve clinical outcomes, as tolerated. The degree to which gaps in medication use and dosing persist in contemporary outpatient practice is unclear. This study seeks to uncover the patterns and factors associated with use and dose of heart failure with reduced ejection fraction (HFrEF) medications in current practice.
SAFE-DCB (C. R. Bard, Inc.):
The purpose of this patient registry is to assess the clinical use of the Lutonix® 035 DCB PTA Catheter in a heterogeneous patient population in a real world and on-label clinical application.
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.
DEFINE FLAIR (Imperial College London in partnership with Volcano Corporation):
This study aims to compare clinical outcomes of patients whose treatment has been guided by iFR to those whose treatment has been guided by FFR. If iFR is found to provide the same clinical outcomes as FFR its adoption will permit the clear benefits of this approach of identifying the coronary narrowings that really need treatment to be applicable to a much larger patient population and further improve healthcare costs.
LIBERTY 360º (Cardiovascular Systems, Inc.):
LIBERTY 360º is a prospective, observational, multi-center study to evaluate procedural and long-term clinical and economic outcomes of endovascular device interventions in patients with symptomatic lower extremity peripheral artery disease (PAD).
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.
Stop Persistent AF (Medtronic, Inc.):
The Sustained Treatment of Paroxysmal Atrial Fibrillation (STOP AF) Trial was designed to confirm the safety and effectiveness of the first generation Arctic Front™ Cardiac Cryoablation System when used to treat patients with drug-refractory†, recurrent symptomatic paroxysmal atrial fibrillation (PAF).
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).
MORE CRT-MPP: MOre REsponse on Cardiac Resynchronization Therapy with MultiPoint Pacing (Abbott Laboratories):
The purpose of this Clinical investigation is to assess the impact of the Multi Point Pacing (MPP) feature at 12 months in the treatment of patients not responding to standard Cardiac Resynchronization Therapy (CRT) after 6 months post-implant of a biventricular pacemaker. Randomization to MPP on or MPP off groups occurs for non-responders at the 6 month follow-up visit.
Principle Investigator: Dr. Ganesh Venkataraman
Sub Investigator: Dr. Layth Saleh