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

NCT02996552 | Recruiting DMC

• 1 other identifier: 072/11
• Study Type: interventional
• Target: 142
• Locations: 2 countries
• Sites: 3

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).

Conditions

Tricuspid Disease; Mitral Regurgitation

Keywords

Tricuspid annulus dilation; mitral valve regurgitation

Outcome Measures

Primary Outcomes (1)

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

  1 year

Secondary Outcomes (2)

• 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)

  5 years

• 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)

  10 years

Study Arms (2)

M & T Repair Group

EXPERIMENTAL

Both mitral and tricuspid valves repair

Procedure: M & T Repair Group

Mitral-Only Group

ACTIVE COMPARATOR

Only mitral valve repair

Procedure: Mitral-Only Group

Interventions

M & T Repair Group PROCEDURE

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

M & T Repair Group

Mitral-Only Group PROCEDURE

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

Mitral-Only Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• patient's refusal
• non-elective cardiac surgery;
• organic disease of tricuspid valve
• TR≥3

Sponsors & Collaborators

• Ospedale San Raffaele: lead
• Istituto Clinico Humanitas: collaborator
• Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland: collaborator

Study Sites (3)

Istituto Clinico Humanitas

Rozzano, Milano, 20089, Italy

RECRUITING

IRCCS Ospedale San Raffaele

Milan, 20132, Italy

RECRUITING

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

Warsaw, 02-507, Poland

RECRUITING

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Michele De Bonis, MD,FESC,FAHA

  IRCCS Ospedale San Raffale Milano

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michele De Bonis, MD,FESC,FAHA

CONTACT

00390226437118; debonis.michele@hsr.it

Cinzia Trumello, MD

CONTACT

00390226437127; trumello.cinzia@hsr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 6, 2016
• First Posted: December 19, 2016
• Study Start: June 8, 2011
• Primary Completion: June 1, 2020
• Study Completion (Estimated): December 1, 2030
• Last Updated: July 21, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2); PL (1)