DuoCor Ventricular Assist System Early Feasibility Study

April 21, 2026 updated by: Shenzhen Core Medical Technology CO.,LTD.

Clincial Use of Implantable Ventricular Assist System for Advanced Heart Failure

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 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.
  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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DuoCor Ventricular Assist System
Device: DuoCor Ventricular Assist System
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite of survival at 3 months post-implantation
Time Frame: 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
3 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shenzhen Core Medical Technology CO.,LTD.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 4, 2024

Primary Completion (Actual)

March 17, 2025

Study Completion (Actual)

June 1, 2025

Study Registration Dates

First Submitted

March 6, 2025

First Submitted That Met QC Criteria

March 12, 2025

First Posted (Actual)

March 17, 2025

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COREMED_DuoCor

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

At this moment the IPD is not yet available for access and will be updated when it is ready.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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