Surgery for mild tricuspid regurgitation during mitral valve repair
Annuloplasty for the Treatment of Not-Severe Tricuspid Regurgitation in Patients Undergoing Surgery for Mitral Valve Disease: a Prospective, Spontaneous, Multicentre, Randomized Study
This study is testing if adding a specific heart surgery for mild tricuspid regurgitation can help patients who are already having mitral valve surgery to avoid future heart problems.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 142 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ospedale San Raffaele Academic / other |
| Locations | 3 sites (Rozzano, Milano and 2 other locations) |
| Trial ID | NCT02996552 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of tricuspid annuloplasty in patients with mild tricuspid regurgitation (TR) undergoing mitral valve surgery. It aims to determine whether performing this procedure in patients with a dilated tricuspid annulus can prevent disease progression. The study is a multicenter, single-blind, parallel group randomized controlled trial, where participants will be randomly assigned to either receive tricuspid annuloplasty or undergo mitral valve repair only. The trial will enroll patients with TR ≤ 2+ and annular dilation to assess the potential benefits of the intervention.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old scheduled for mitral valve surgery with mild tricuspid regurgitation and a dilated tricuspid annulus.
Not a fit: Patients with severe tricuspid regurgitation (TR ≥ 3) or organic disease of the tricuspid valve may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide evidence for a surgical approach that prevents the progression of tricuspid disease in patients undergoing mitral valve surgery.
How similar studies have performed: While some observational studies suggest potential benefits, this approach remains controversial and lacks robust evidence from randomized trials.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * age \> 18 years; * ability to provide informed consent; * patients scheduled for mitral valve regurgitation * TR ≤ 2+ with annular dilation * Tricuspid diastolic diameter ≥ 40 mm or 21 mm/m2 Exclusion Criteria: * patient's refusal * non-elective cardiac surgery; * organic disease of tricuspid valve * TR≥3
Where this trial is running
Rozzano, Milano and 2 other locations
- Istituto Clinico Humanitas — Rozzano, Milano, Italy (Recruiting)
- IRCCS Ospedale San Raffaele — Milan, Italy (Recruiting)
- Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland — Warsaw, Poland (Recruiting)
Study contacts
- Principal investigator: Michele De Bonis, MD,FESC,FAHA — IRCCS Ospedale San Raffale Milano
- Study coordinator: Michele De Bonis, MD,FESC,FAHA
- Email: debonis.michele@hsr.it
- Phone: 00390226437118
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.