DuoCor Ventricular Assist System Early Feasibility Study

Not Applicable

Recruiting

• Conditions: Heart Failure

• Registration Number: NCT06878508
• Lead Sponsor: Shenzhen Core Medical Technology CO.,LTD.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-04
• Status Verified: 2025-03
• Study First Submitted: 2025-03-06
• Study First Submitted QC: 2025-03-12
• Last Update Submitted: 2025-03-12
• Study First Posted: 2025-03-17
• Last Update Posted: 2025-03-17
• Primary Completion: 2026-10-01
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. 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.

2. Patient has signed the informed consent, has full understanding of procedures, and is committed to following study requirements.

Exclusion Criteria

1. Intolerance to anticoagulant or antiplatelet therapies or any other peri/post-operative therapy the investigator will require based upon the patient's health status.
2. 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.
3. Pregnancy.
4. Age > 75 years.
5. Presence of an active, uncontrolled infection.
6. Brain death.
7. History of confirmed, untreated abdominal aortic aneurysm (AAA) or thoracic aortic aneurysm (TAA) > 5 cm in diameter.
8. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Composite of survival at 3 months post-implantation	3 months	Composite of survival to transplant, recovery (defined as complete/ partial removal or explantation of the DuoCor VAS due to cardiac recovery), or survival with the device at 3 months post-implantation

Secondary Outcome Measures

Name	Time	Method
Hospital redmission rate	3 months	Rate of unplanned readmissions to the hospital.
Adverse Events.	3 months	Adverse Event as defined in INTERMACS Adverse Events (Definition Date: 10/11/2021)

Trial Locations

Locations (1)

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China