Comparing Allografts and Bioprosthetic Valves for Tricuspid Valve Disease
Clinical Efficacy and Long-term Outcomes of Allograft Versus Stented Biological Prosthesis for Primary Tricuspid Valve Disease
This study tests whether using donated heart valves or artificial valves is safer and more effective for people getting surgery for tricuspid valve disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 56 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Chelyabinsk Regional Clinical Hospital Government |
| Locations | 1 site (Chelyabinsk) |
| Trial ID | NCT06591000 on ClinicalTrials.gov |
What this trial studies
This study evaluates the early safety and long-term outcomes of using mitral allografts versus stented biological prostheses in patients undergoing tricuspid valve replacement for primary tricuspid valve diseases. It will assess morbidity, mortality rates, and freedom from valve-related complications, as well as survival rates and the need for reoperations. The study will utilize echocardiographic assessments and MSCT scans to gather comprehensive data on both treatment groups.
Who should consider this trial
Good fit: Ideal candidates include patients with primary tricuspid valve disease or 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 study could provide insights into the most effective treatment options for patients with tricuspid valve disease, potentially improving patient outcomes.
How similar studies have performed: While there have been studies on valve replacements, this specific comparison of allografts versus stented biological prostheses in tricuspid valve disease is relatively novel.
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 40%
Where this trial is running
Chelyabinsk
- Department of Cardiac Surgery — Chelyabinsk, Russia (Recruiting)
Study contacts
- Study coordinator: Mikhail Nuzhdin, PhD
- Email: austesla2022@gmail.com
- Phone: 0079068608612
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.