NCT07675005Not yet recruiting
The Prospective, Multicenter, Randomized Controlled Trial of the VentriCure Interventional Left Ventricular Assist System
The Prospective, Multicenter, Randomized Controlled Clinical Trials Comparing the VentriCure Left Ventricular Assist System With ECMO for Supporting High-risk PCI Procedures
Source: ClinicalTrials.gov · Last updated 30 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 220 (estimated)
- First submitted
- 23 Jun 2026
- Start date
- 30 Jul 2026
- Primary completion date
- 30 Oct 2028
- Lead sponsor
- Life Shield Medical Technology Co., LTD
- Diseases
- Coronary artery disease
- NCT number
- NCT07675005
What you commit to
- Study type: Interventional
- Planned participants: 220
- From 30 Jul 2026 to the primary completion date, 30 Oct 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Cardiac arrest within 24 hours;
- ST-segment elevation myocardial infarction (STEMI) within 24 hours;
- Chronic Kidney Disease;
- Severe right heart failure or severe tricuspid regurgitation;
- History of stroke or transient ischemic attack (TIA) within one month;
- Allergy or intolerance to anticoagulants or contrast agent;
- Active internal bleeding within a month;
- Presence of uncontrolled active infection;
Lab values
- Presence of abnormal coagulation parameters (platelet count ≤75,000/mm\^3, INR≥2.0, or fibrinogen ≤1.50g/L);
Other
- The implantation of an interventional left ventricular assist system was either contraindicated or not feasible;
- Moderate or higher anemia;
- Pregnant or lactating women;
- Patients are participating in other clinical trials;
- Other circumstances that are determined by the investigator to be unsuitable for the study.
Who the study is looking for
- 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:
- (1) Coronary Artery Disease and left ventricular ejection fraction ≤35%; (2) Coronary Artery Disease and left ventricular ejection fraction ≤40% and severe heart failure; 4. PCI was required for imaging diagnosis; 5. Patient willing and able to comply with protocol requirements and accept clinical follow-up; able to understand study purpose and sign informed consent.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.