The Prospective, Multicenter, Randomized Controlled Trial of the VentriCure Interventional Left Ventricular Assist System

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLife Shield Medical Technology Co., LTD

About this trial

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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • VentriCure Interventional left ventricular assist system
  • ECMO

Treatment groups

220 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Life Shield Medical Technology Co., LTD

Lead sponsor