Evaluating the use of mitral allografts in tricuspid valve surgery
Early Safety and Clinical Efficacy of Mitral Allografts in Patients With Primary Tricuspid Valve Disease Scheduled for Tricuspid Valve Replacement
This study is testing whether using mitral allografts during tricuspid valve surgery can help patients recover safely and avoid complications.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Chelyabinsk Regional Clinical Hospital Government |
| Locations | 1 site (Chelyabinsk) |
| Trial ID | NCT06196684 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the early safety and clinical efficacy of mitral allografts used in tricuspid valve replacement for patients with primary tricuspid valve diseases. It will evaluate morbidity and mortality rates, as well as freedom from valve-related complications in the early postoperative period. Additionally, mid-term outcomes such as survival rates and the need for reoperation will be monitored. The study focuses on patients scheduled for tricuspid valve intervention based on intraoperative findings.
Who should consider this trial
Good fit: Ideal candidates include patients with primary tricuspid valve disease or tricuspid bioprosthetic failure who are scheduled for tricuspid valve intervention.
Not a fit: Patients with secondary tricuspid valve pathology or significant left-sided valve disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve surgical outcomes and reduce complications for patients undergoing tricuspid valve replacement.
How similar studies have performed: While this approach is being evaluated, similar studies have shown promise in using allografts for valve replacement, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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%
Where this trial is running
Chelyabinsk
- Department of Cardiac Surgery — Chelyabinsk, Russian Federation (Recruiting)
Study contacts
- Study coordinator: Mikhail Nuzhdin
- Email: austesla2022@gmail.com
- Phone: +79068608612
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.