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Annuloplasty for Not-Severe TR in Patients Undergoing MV Repair Versus Mitral Repair Only (NOSTRUM)

ConditionsTricuspid DiseaseMitral Regurgitation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOspedale San Raffaele

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

age > 18 years;

ability to provide informed consent;

patients scheduled for mitral valve regurgitation

TR ≤ 2+ with annular dilation

Disqualifiers

patient's refusal

non-elective cardiac surgery;

organic disease of tricuspid valve

TR≥3

Trial design

Design model

Parallel

Treatments tested in this trial

  • M & T Repair Group

    Procedure/Surgery

    After the mitral valve repair a device for tricuspid annuloplasty will be implanted.

  • Mitral-Only Group

    Procedure/Surgery

    Mitral valve repair alone; after the mitral valve repair no device for tricuspid annuloplasty will be implanted.

Treatment groups

142 Participants
are divided into 2 treatment groups
Group A: M & T Repair GroupExperimental treatment 1 intervention
Group B: Mitral-Only GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

The 1-year freedom from recurrence of TR≥3+ and from progression by 2 degrees compared to pre-operative.

Time frame
1 year

Secondary outcomes

1

The 5-year freedom from recurrence of TR >= 3+ and from progression by 2 degrees compared to pre-operative, in the combined treatment group (M & T Repair Group) and in the single treatment group ( Mitral-Only Group)

Time frame
5 years
2

The 10-year freedom from recurrence of TR >= 3+ and from progression by 2 degrees compared to pre-operative, in the combined treatment group (M & T Repair Group) and in the single treatment group ( Mitral-Only Group)

Time frame
10 years

Other outcomes

Sponsors and contacts

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Ospedale San Raffaele

Lead sponsor

Istituto Clinico Humanitas

Collaborator

Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland

Collaborator

Source ClinicalTrials.gov
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