Feasibility of the DuoCor Ventricular Assist System for heart failure treatment
Clincial Use of Implantable Ventricular Assist System for Advanced Heart Failure
This study is testing a new heart device called the DuoCor Ventricular Assist System to see if it can help people with severe heart failure feel better and improve their heart function.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Shenzhen Core Medical Technology CO.,LTD. Industry-sponsored |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT06878508 on ClinicalTrials.gov |
What this trial studies
This study evaluates the DuoCor Ventricular Assist System as a potential treatment for patients with advanced total heart failure. It focuses on individuals who require biventricular mechanical circulatory support due to persistent heart failure or refractory right heart failure after LVAD implantation. Participants will be monitored for their response to this innovative device, which aims to improve heart function and patient outcomes. The study involves informed consent and adherence to specific medical protocols.
Who should consider this trial
Good fit: Ideal candidates are patients experiencing advanced total heart failure despite optimal medical management or those with refractory right heart failure post-LVAD.
Not a fit: Patients who cannot tolerate anticoagulant therapies or have anatomical issues preventing device implantation may not benefit from this study.
Why it matters
Potential benefit: If successful, this could provide a new treatment option for patients with severe heart failure who have limited alternatives.
How similar studies have performed: While this approach is innovative, similar studies exploring mechanical circulatory support have shown promise in improving outcomes for heart failure patients.
Eligibility criteria
Show full inclusion / exclusion 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. 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.
Where this trial is running
Wuhan, Hubei
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
Study contacts
- Study coordinator: Xiaoli Shi
- Email: shixiaoli@coretechmed.com
- Phone: +86 13418601356
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.