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.
CHAMPION-AF (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 non-vitamin K oral anticoagulants in patients with non-valvular atrial fibrillation
- Principle Investigator: Dr. Ganesh Venkataraman
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
STEMI-DTU (Abiomed):
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:
- Reduction in Infarct Size
- Reduction in the Incidence of Heart Failure-related clinical events
- An acceptable safety profile
- Principle Investigator: Dr Nima Aghili
- Sub Investigator: Dr John Altman, Dr David Halpin, Dr Lawrence Lazar
SyncAV (Abbott):
The SyncAV Post-Market Trial is a prospective, randomized, multi-center trial performed to determine if cardiac resynchronization therapy (CRT) devices programmed with SyncAV ON improve long-term CRT response compared to devices programmed with conventional CRT through evaluation of changes in left ventricular (LV) reverse remodeling.
- Principal Investigator: Dr Ganesh Venkataraman
- Sub Investigator: Dr Layth Saleh
DEFINE-GPS (Volcano):
A study comparing PCI guided by angiography versus iFR Co-Registration using commercially available Philips pressure guidewires and the SyncVision co-registration system, employing an adaptive design study for interim sample size re-estimation.
- Principle Investigator: Dr John Altman
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
AGENT-IDE (Boston Scientific):
The purpose of this study is to assess the safety and effectiveness of the Agent Paclitaxel Coated PTCA Balloon Catheter compared to balloon angioplasty (POBA) in patients with in-stent restenosis (ISR) of a previously treated lesion of up to 26 mm in length (by visual estimate) in a native coronary artery 2.0 mm to 4.0 mm in diameter.
- Principle Investigator: Dr John Altman
TARGET BPI (Ablative Solutions):
This is a randomized, blinded, multi-center, international, sham-procedure controlled trial, comparing renal denervation performed with the Peregrine System Kit in the treatment group to the sham control group (without renal denervation – no alcohol infusion).
- Principle Investigator: Dr John Altman
SAFE-STEMI:
Patients with partially blocked blood vessel(s) in their heart may need a medical procedure called “Percutaneous Coronary Intervention (PCI)” to open the narrowed blood vessel(s). The purpose of this study is to simultaneously address four potential advances in ST-Elevation Myocardial Infarction (STEMI) care for patients at least 65 years old. The investigators are looking to see if these advances can improve the outcome for these patients.
- Opening the arteries with a Medtronic stent
- Radial access (from wrist) success with a Medtronic stent
- Checking the percent of blockage in the diseased artery/arteries using Volcano guide wires.
- Reduced bleeding and vascular complications with radial arterial access for primary PCI in STEMI.
- 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 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).
Humanitarian Use Device PK Papyrus Coronary Stent (Biotronik):
The purpose of this study is to research the efficacy of the FDA approved PK Papyrus Coronary Stent Graft System.