DuoCor Ventricular Assist System Early Feasibility Study

Shenzhen Core Medical Technology

Status

Enrolling

Conditions

Heart Failure

Treatments

Device: DuoCor Ventricular Assist System

Study type

Interventional

Funder types

Industry

Identifiers

COREMED_DuoCor

Details and patient eligibility

About

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

Enrollment

10 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Requiring a biventricular mechanical circulatory support, defined by either of the following criteria:
- Persistent total heart failure despite under optimal medical management based on current heart failure practice guidelines. OR
- Development of refractory right heart failure following left ventricular assist device (LVAD) implantation, unresponsive to pharmacological interventions for right heart failure.
Patient has signed the informed consent, has full understanding of procedures, and is committed to following study requirements.

Exclusion criteria

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.