Surgery for mild tricuspid regurgitation during mitral valve repair

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.