The Prospective, Multicenter, Randomized Controlled Trial of the VentriCure Interventional Left Ventricular Assist System
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: VentriCure Interventional left ventricular assist system, ECMO.
- Who it may be relevant to
- Registry conditions: Coronary Artery Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Prospective, Multicenter, Randomized Controlled Clinical Trials Comparing the VentriCure Left Ventricular Assist System With ECMO for Supporting High-risk PCI Procedures
Overview
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.
Interventions
- Device VentriCure Interventional left ventricular assist system
The VentriCure interventional left ventricular assist system provides hemodynamics support for intraoperative protection during high-risk percutaneous coronary intervention. - Device ECMO
Subjects with coronary artery disease receiving high-risk PCI will be supported by the Extracorporeal Membrane Oxygenation System during the procedure.
Primary outcome measures
- Incidence of major adverse events at 30 days post-PCI [Time frame: 30 days post-PCI]
Eligibility criteria
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:
(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.
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;
- Allergy or intolerance to anticoagulants or contrast agent;
- Active internal bleeding within a month;
- Presence of uncontrolled active infection;
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07675005 · VentriCure