CompletedNot Applicable

DuoCor Ventricular Assist System Early Feasibility Study

China8 participantsStarted 2024-07-04

Plain-language summary

Feasibility study of the DuoCor Ventricular Assist System as a treatment for advanced total heart failure patients.

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Adult patients who require biventricular mechanical circulatory support, defined by either of the following criteria:
✓. Patient has signed the informed consent, has full understanding of procedures, and is committed to following study requirements.

✕. Intolerance to anticoagulant or antiplatelet therapies or any other peri/post-operative therapy the investigator will require based upon the patient's health status.
✕. Technical obstacles which pose the implantation as unsuitable, obtaining the body type, body surface area, and anatomical conditions related to the planned implantation site, in the judgment of the experienced investigators.
✕. Pregnancy.
✕. Age \> 75 years.
✕. Presence of an active, uncontrolled infection.
✕. Brain death.
✕. History of confirmed, untreated abdominal aortic aneurysm (AAA) or thoracic aortic aneurysm (TAA) \> 5 cm in diameter.
✕. Irreversible cognitive dysfunction, psychosocial issues, or psychiatric disease, likely to impair compliance with the study protocol and DuoCor VAS management which, in the opinion of the investigator, could interfere with the ability to manage the therapy.

Composite of survival at 3 months post-implantation

Timeframe: 3 months

NCT IDNCT06878508

SponsorShenzhen Core Medical Technology CO.,LTD.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-03-17