Early Safety and Clinical Efficacy of Mitral Allograft in Tricuspid Surgery

Launched by CHELYABINSK REGIONAL CLINICAL HOSPITAL · Dec 26, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at the safety and effectiveness of using mitral allografts (a type of heart tissue from a donor) in surgeries for patients with tricuspid valve issues. The tricuspid valve helps control blood flow between the heart’s upper and lower chambers on the right side, and sometimes it needs to be replaced, especially if a previous artificial valve is not working properly. The study is currently recruiting participants aged between 18 and 80 who have primary tricuspid valve disease and need a replacement rather than a repair during surgery.

To be eligible, participants must be scheduled for tricuspid valve surgery and show that their condition requires a valve replacement based on what doctors find during surgery. However, some people won't be able to join, such as those who are pregnant, have certain infections like HIV, or have significant heart function issues. Participants in the trial can expect to be closely monitored during and after their surgery to see how well the new valve works and to ensure their safety throughout the process.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients with primary tricuspid valve disease and/or tricuspid bioprosthetic failure scheduled for tricuspid valve intervention.
• • Intraoperative findings suggested for tricuspid valve replacement rather than repair.
• Exclusion Criteria:
• • Pregnancy
• • Confirmed active drug addiction
• • Progressive HIV-infection
• • HIV-infected patients with CD4-cells count less than 250
• • Patients with secondary tricuspid valve pathology (left-sided valve disease)
• • LV Ejection fraction less than 50%