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
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:
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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 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
Aveir DR (Abbott)
A prospective, non-randomized, multi-center, international study designed to evaluate the safety and effectiveness of the Aveir™ Dual-Chamber (DR) Leadless Pacemaker system in a patient population indicated for a DDD® pacemaker.
Principle Investigator: Dr. Sri Sundaram
Sub Investigator: Dr. Ganesh Venkataraman
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
Sub Investigator: Dr. Ashwin Murthy
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
Sub Investigator: Dr. Nima Aghili
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
Sub Investigator: Dr. David Halpin, Dr. Nima Aghili, Dr. Ahmad Alqaqaa, Dr. Ashwin Murthy
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.
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Opening the arteries with a Medtronic stent
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Radial access (from wrist) success with a Medtronic stent
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Checking the percent of blockage in the diseased artery/arteries using Volcano guide wires.
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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 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.
Enrolling Soon:
PROTECT IV (Abiomed)
The purpose of this study is to demonstrate that in high-risk patients with complex Coronary Heart Disease (CAD) and reduced left ventricular function undergoing PCI, PCI with Impella MCS is superior to PCI without Impella MCS in reducing the composite rate of all-cause death, stroke, durable LVAD implant or heart transplant, MI or hospitalization for cardiovascular causes at 3-year follow-up.
Principle Investigator: Dr. Nima Aghili
VICTORIAN-INCEPTION KJX839 (Novartis)
The purpose of this study is to study the effectiveness of implementation of a systematic LDL-C management pathway including treatment with inclisiran in participants who have experienced a recent acute coronary syndrome (ACS) and have an increased LDL-cholesterol (≥70 mg/dL) despite being treated with a statin drug.
Principle Investigator: Dr. John Altman
PARAGLIDE (Novartis)
The purpose of this study is to assess the effect of sacubitril/valsartan vs. valsartan on changes in NT-proBNP, safety, and tolerability in Heart failure with preserved ejection fraction (HFpEF) patients with a WHF event (HFpEF decompensation) who have been stabilized and initiated at the time of or within 30 days post-decompensation
Principle Investigator: Dr. Frederico Trobo
FROST-HF (Occlutech)
The purpose of this clinical study is to assess the safety and effectiveness of the Atrial Flow Regulator in the treatment of subjects, 18 years of age or older, who have symptomatic heart failure with preserved ejection fraction (HFpEF) or heart failure with reduced ejection fraction (HFrEF) while on stable guideline directed medical therapy (GDMT) as outlined in the Guidelines for the Management of Heart Failure.
Principle Investigator: Dr. Nima Aghili
OCCLUFLEX (Occlutech)
The objective of this study is to investigate whether percutaneous PFO closure with the Occlutech Flex II PFO Occluder is non-inferior to the AMPLATZER™ PFO Occluder and Gore® Cardioform Septal Occluder in closure of the PFO, prevention of recurrent embolic stroke, and device/procedure related Serious Adverse Events (SAE).
Principle Investigator: Dr. Nima Aghili
Resonance Registry (Kiniksa)
The registry will focus on furthering the understanding of the natural history of recurrent pericarditis (RP), as well as document RP-related clinical, health-related quality of life (HRQoL), and economic burden and will assist the medical community to refine or develop data-driven recommendations for clinical management of RP patients to optimize clinical outcomes. It also aims to generate data in support of the impact of rilonacept on clinical outcomes in a real-world population.
Principle Investigator: Dr. Kristin Thanvaro
Pufferfish (Verily)
This is a prospective, non-randomized feasibility study that will gather data on heart failure patients