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RECRUITING
NCT07769528
NA

Safety and Efficacy of the Extracorporeal Ventricular Assist System in Car Diogenic Shock: A Prospective, Multicenter , Single-Arm Study

Sponsor: China National Center for Cardiovascular Diseases

View on ClinicalTrials.gov

Summary

Study Title: Safety and Efficacy of Extracorporeal Ventricular Assist System for Cardiogenic Shock: A Prospective, Multicenter, Single-Arm Clinical Study Objective: To evaluate the safety and efficacy of temporary mechanical circulatory support and bridge therapy with an extracorporeal ventricular assist system in patients with cardiogenic shock or weaning failure from cardiopulmonary bypass, and to comprehensively assess the device, pump head, cannulae and tubing. Pilot Phase: Clinical validation of Class III medical device. Study Design: Prospective, multicenter, single-arm target-value design. Sample Size: 40 patients. Primary Endpoint: Success rate of mechanical circulatory support. Secondary Endpoints: 30-day survival after transition to long-term therapy (VAD/transplant); 30-day cardiovascular mortality after device explantation; MACCE incidence; Mean support duration; Incidence of bleeding, thrombosis, hematologic events, acute renal/hepatic dysfunction, infection; Hemodynamic trends during support; Changes in SCr, BUN, ALT, TBIL at use, discharge and 30 days post-explantation vs baseline; Device satisfaction. Follow-up: Within 6 hours of initiation, during support, 24 hours, 7 days, 30 days post-explantation/transition, and at discharge. All clinical data were collected, managed and analyzed by an independent data and statistical center and clinical monitoring unit to support safety/efficacy evaluation and market approval.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-03-23

Completion Date

2028-12-31

Last Updated

2026-08-18

Healthy Volunteers

No

Interventions

PROCEDURE

EVAS Treatment

Using interventional implantation of blood conduits into the left cardiac system, an extracorporeal pump shunts blood to the arterial system to partially or fully substitute cardiac pumping function and sustain systemic circulation.

Locations (1)

Fuwai Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China