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DuoCor Ventricular Assist System Early Feasibility Study | Clinical Trials | Clareo Health

RECRUITINGNA

DuoCor Ventricular Assist System Early Feasibility Study

Clincial Use of Implantable Ventricular Assist System for Advanced Heart Failure

NCT06878508•Shenzhen Core Medical Technology CO.,LTD.

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

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

Wuhan, Hubei, China

Key Dates

Start Date

July 4, 2024

Primary Completion Date

October 1, 2026

Completion Date

October 1, 2026

Last Updated

March 17, 2025

Enrollment

ESTIMATED participants

Conditions

Heart Failure

Interventions

DuoCor Ventricular Assist System

DEVICE

Contacts

Xiaoli Shi

CONTACT

+86 13418601356 shixiaoli@coretechmed.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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DuoCor Ventricular Assist System Early Feasibility Study

Inclusion Criteria

Exclusion Criteria

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