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Recruiting NCT06878508

DuoCor Ventricular Assist System Early Feasibility Study

Trial Parameters

Condition Heart Failure
Sponsor Shenzhen Core Medical Technology CO.,LTD.
Study Type INTERVENTIONAL
Phase N/A
Enrollment 10
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2024-07-04
Completion 2026-10-01
Interventions
DuoCor Ventricular Assist System

Brief Summary

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

Eligibility Criteria

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

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