Condition: Tricuspid Disease · Mitral Regurgitation · Sponsor: Ospedale San Raffaele
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 …
This description comes directly from the study's public registry record.
Michele De Bonis, MD,FESC,FAHA · 00390226437118 · debonis.michele@hsr.it
Cinzia Trumello, MD · 00390226437127 · trumello.cinzia@hsr.it
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| 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 |
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Source record: clinicaltrials.gov/study/NCT02996552