Annuloplasty for the Treatment of Not-Severe Tricuspid Regurgitation in Patients Undergoing Surgery for Mitral Valve Disease: a Prospective, Spontaneous, Multicentre, Randomized Study

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The surgical treatment of less than severe (≤2+/4+) functional tricuspid regurgitation (TR) in patient undergoing mitral valve surgery, is still controversial: some observational studies have suggested that performing tricuspid annuloplasty in patients undergoing mitral valve surgery with a dilated tricuspid annulus, and TR≤2+ may provide a clinical benefit, while in other observational studies such benefit has not been documented. The ESC Guidelines assign the class IIa recommendation for surgical treatment in patients with tricuspid regurgitation ≤2+ and a dilated annulus, if surgery is concomitant to the repair or replacement of the mitral valve. However the level of evidence C (expert opinion) confirms the absence of clear scientific evidence to support this recommendation. It is therefore very important to carry out randomized trials designed to really prove the supposed efficacy of prophylactic tricuspid annuloplasty, especially in patients with degenerative etiology where the data are particularly controversial. The aim of the study will be to establish the effectiveness of the tricuspid annuloplasty in the early stage of TR. The investigators enrolled patients with TR≤2+ and annular dilation undergoing mitral valve repair. Primary end-point will be the freedom from recurrence of TR≥3+ and from progression of 2 degrees of TR compared to pre-operative, at discharge and 12 months after surgery, assessment by transthoracic echocardiography. Secondary endpoints are to demonstrate the superiority of combined treatment (M \& T Repair Group) compared to single treatment (Mitral-Only Group) at 5 and 10 years after surgery. This will be an experimental superiority, prospective, spontaneous, multicenter, randomized trial. Patients will be randomly assigned to two parallel arms with an allocation ratio 1:1 stratified by center, to receive mitral repair only (Mitral-Only group) or both mitral and tricuspid repair (M \& T Repair group).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
IRCCS Ospedale San Raffaele
RECRUITING
Milan
Istituto Clinico Humanitas
RECRUITING
Rozzano
Poland
Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland
RECRUITING
Warsaw
Contact Information
Primary
Michele De Bonis, MD,FESC,FAHA
debonis.michele@hsr.it
00390226437118
Backup
Cinzia Trumello, MD
trumello.cinzia@hsr.it
00390226437127
Time Frame
Start Date: 2011-06-08
Estimated Completion Date: 2030-12
Participants
Target number of participants: 142
Treatments
Experimental: M & T Repair Group
Both mitral and tricuspid valves repair
Active_comparator: Mitral-Only Group
Only mitral valve repair
Sponsors
Collaborators: Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland, Istituto Clinico Humanitas
Leads: Ospedale San Raffaele

This content was sourced from clinicaltrials.gov