DuoCor Ventricular Assist System Early Feasibility Study

NCT06878508 | Completed

• 1 other identifier: COREMED_DuoCor
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Composite of survival at 3 months post-implantation

  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

  3 months

Secondary Outcomes (2)

• Hospital redmission rate

  3 months

• Adverse Events.

  3 months

Study Arms (1)

DuoCor Ventricular Assist System

EXPERIMENTAL

Device: DuoCor Ventricular Assist System

Interventions

DuoCor Ventricular Assist System DEVICE

The DuoCor VAS is used to provide hemodynamic support by shareing some or all the workload of the left and right ventricles during the support period.

DuoCor Ventricular Assist System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients who require biventricular mechanical circulatory support, defined by either of the following criteria:
• Persistent total heart failure despite 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shenzhen Core Medical Technology CO.,LTD.: lead

Study Sites (1)

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: March 17, 2025
• Study Start: July 4, 2024
• Primary Completion: March 17, 2025
• Study Completion: June 1, 2025
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)