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.
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:
1. Reduction in Infarct Size
2. Reduction in the Incidence of Heart Failure-related clinical events
3. 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
Sub Investigator: Dr. Ashwin Murthy
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.
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
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
ReliaSeal (Cordis)
ReliaSeal is a clinical trial designed to evaluate safety and efficacy of use of MYNX CONTROL™ Venous Vascular Closure Device 6F-12F vs. manual compression to seal femoral access sites in patients who have undergone endovascular procedures utilizing up to 12F procedural sheaths in one or both limbs.
Principle Investigator: Dr. Layth Saleh
Sub Investigator: Dr Ganesh Venkataraman, Dr Parth Makker
CHANGE AFib (American Heart Association)
The purpose of this study is to determine if treatment with dronedarone on top of usual care is superior to usual care alone for the prevention of cardiovascular hospitalization or death from any cause in patients hospitalized with first-detected AF.
Principle Investigator: Dr Ganesh Venkataraman
Sub Investigator: Dr Layth Saleh, Dr Parth Makker
CERAMICS (Henry Ford Institue)
The CERAMICS study is designed to more clearly delineate the current care of acute myocardial infarction with cardiogenic shock (AMICS) patients who are treated with mechanical circulatory support (MCS) devices in the United States with significant experience in MCS, all of whom have the capability of MCS escalation on-site.
Principle Investigator: Dr Nima Aghili
Enrolling Soon:
Blood Flow (Colorado Heart and Vascular)
The objective is to determine a non-invasive and affordable method of measuring cardiac output. Comparing cardiac output as measured by a Right Heart Catheter and Muscle oxy-hemoglobin level as measured with a NIRS device, will allow for a correlation of these two methods.
Principle Investigator: Dr Nima Aghili, Dr John Altman