The Prospective, Multicenter, Randomized Controlled Trial of the VentriCure Interventional Left V… (NCT07675005) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The Prospective, Multicenter, Randomized Controlled Trial of the VentriCure Interventional Left Ventricular Assist System
220 participantsStarted 2026-07-30
Plain-language summary
This study aims to evaluate the safety and effectiveness of the VentriCure interventional left ventricular assist system for short-term ventricular support during high-risk percutaneous coronary intervention (HRPCI) in non-emergent, hemodynamically stable coronary artery disease patients via a prospective, multi-center, randomized controlled clinical trial.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patient age ≥18 years old;
. As assessed by the cardiac team the patient needs coronary revascularization, but CABG (Coronary Artery Bypass Grafting) is of high risk, or the patient refuses to undergo CABG;
. The patient is meeting one of the following:
Exclusion criteria
. Cardiac arrest within 24 hours;
. The implantation of an interventional left ventricular assist system was either contraindicated or not feasible;
. ST-segment elevation myocardial infarction (STEMI) within 24 hours;
. Chronic Kidney Disease;
. Severe right heart failure or severe tricuspid regurgitation;
. Presence of abnormal coagulation parameters (platelet count ≤75,000/mm\^3, INR≥2.0, or fibrinogen ≤1.50g/L);
. Moderate or higher anemia;
. History of stroke or transient ischemic attack (TIA) within one month;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is listed as 'not yet recruiting' — do you know when it's expected to open, and would waiting for it delay any treatment I need now for my coronary artery disease?
2The trial is testing a left ventricular assist device used during a procedure called PCI — can you explain what that device actually does during the procedure and why my case might or might not be a good fit for that kind of support?
3The main thing being measured is serious adverse events at 30 days after PCI — what kinds of complications are they tracking, and how does that safety picture compare to having PCI without this device?
4Since this trial doesn't have a traditional phase label, what does that tell us about how much is already known about the VentriCure device's safety and effectiveness, and should that affect how I think about enrolling?
5Would standard PCI without a left ventricular assist device be a reasonable option for me right now, or is there a reason my doctor thinks a trial like this one might be worth waiting for or pursuing?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of major adverse events at 30 days post-PCI