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

NCT07769528 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-08-18

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • China National Center for Cardiovascular Diseases

    lead OTHER_GOV

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-23
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07769528 on ClinicalTrials.gov