NCT02996552 Annuloplasty for Not-Severe TR in Patients Undergoing MV Repair Versus Mitral Repair Only (NOSTRUM)
| NCT ID | NCT02996552 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ospedale San Raffaele |
| Condition | Tricuspid Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 142 participants |
| Start Date | 2011-06-08 |
| Primary Completion | 2020-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 142 participants in total. It began in 2011-06-08 with a primary completion date of 2020-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Michele De Bonis, MD,FESC,FAHA
PRINCIPAL INVESTIGATOR
IRCCS Ospedale San Raffale Milano
Frequently Asked Questions
Who can join the NCT02996552 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Tricuspid Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02996552 currently recruiting?
Yes, NCT02996552 is actively recruiting participants. Contact the research team at debonis.michele@hsr.it for enrollment information.
Where is the NCT02996552 trial being conducted?
This trial is being conducted at Rozzano, Italy, Milan, Italy, Warsaw, Poland.
Who is sponsoring the NCT02996552 clinical trial?
NCT02996552 is sponsored by Ospedale San Raffaele. The principal investigator is Michele De Bonis, MD,FESC,FAHA at IRCCS Ospedale San Raffale Milano. The trial plans to enroll 142 participants.