DuoCor Ventricular Assist System Early Feasibility Study

Launched by SHENZHEN CORE MEDICAL TECHNOLOGY CO.,LTD. · Mar 12, 2025

Keywords

ClinConnect Summary

The DuoCor Ventricular Assist System Early Feasibility Study is researching a new treatment option for patients with severe heart failure. This study is looking for people who still have serious heart problems despite receiving the best available medical care or those who have developed new heart issues after already having a left ventricular assist device (a device that helps pump blood for people with weakened hearts). The goal is to see if the DuoCor system can help these patients live better, healthier lives.

To participate in this study, candidates should be between 65 and 75 years old, have heart failure that isn't responding to standard treatments, and be able to understand and agree to the study's requirements. However, there are some reasons why someone might not be eligible, such as being over 75 years old, having certain infections, or having other serious health issues. If chosen for the trial, participants will receive the DuoCor device, and the team will closely monitor their health and well-being throughout the study. This trial is currently recruiting new participants, and it offers a chance to be part of a potentially important advancement in heart failure treatment.

Gender

ALL

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. 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.