DuoCor Ventricular Assist System Early Feasibility Study
NCT ID: NCT06878508
Last Updated: 2025-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
10 participants
INTERVENTIONAL
2024-07-04
2026-10-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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DuoCor Ventricular Assist System
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.
Interventions
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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.
Eligibility Criteria
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Inclusion 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
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.
18 Years
75 Years
ALL
No
Sponsors
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Shenzhen Core Medical Technology CO.,LTD.
INDUSTRY
Responsible Party
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Locations
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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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COREMED_DuoCor
Identifier Type: -
Identifier Source: org_study_id
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