Actively Recruiting
Annuloplasty for the Treatment of Not-Severe Tricuspid Regurgitation in Patients Undergoing Surgery for Mitral Valve Disease: a Prospective, Multicenter, Randomized Study
Led by Ospedale San Raffaele · Updated on 2020-07-21
142
Participants Needed
3
Research Sites
547 weeks
Total Duration
On this page
Sponsors
O
Ospedale San Raffaele
Lead Sponsor
I
Istituto Clinico Humanitas
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of surgical treatment for less severe functional tricuspid regurgitation (TR) in patients undergoing mitral valve surgery. The study focuses on patients with mild to moderate TR (grade 2 or less) and a dilated tricuspid annulus, where current guidelines recommend surgery but lack strong scientific evidence. This multicenter, randomized trial aims to clarify whether adding tricuspid annuloplasty to mitral valve repair improves outcomes, especially in patients with degenerative disease causes. Participants will be randomly assigned to one of two groups: one receiving mitral valve repair alone (Mitral-Only Group) and the other receiving both mitral valve repair and tricuspid annuloplasty using an Edwards MC3 Tricuspid ring (M & T Repair Group). The surgical procedures occur during the same operation, with patients blinded to their group assignment. Each group will include 71 patients. During the study, researchers will monitor patients for recurrence or worsening of tricuspid regurgitation by at least two grades using transthoracic echocardiography at discharge and 12 months after surgery. They will also assess long-term outcomes at 5 and 10 years. Safety, freedom from reoperation, and progression of TR will be evaluated using statistical methods. Participants will be followed for up to 10 years after surgery.
CONDITIONS
Brief Title
Annuloplasty for Not-Severe TR in Patients Undergoing MV Repair Versus Mitral Repair Only (NOSTRUM)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than 18 years
- Ability to provide informed consent
- Scheduled for mitral valve regurgitation surgery
- Tricuspid regurgitation grade 2 or less with annular dilation
- Tricuspid diastolic diameter of 40 mm or more, or 21 mm/m2 or more
You will not qualify if you...
- Patient's refusal to participate
- Non-elective (emergency) cardiac surgery
- Presence of organic disease of the tricuspid valve
- Tricuspid regurgitation grade 3 or higher
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo mitral valve repair surgery. Depending on randomization, some participants will also receive tricuspid annuloplasty during the surgery.
1 visit (in-person)
Duration - Up to 10 years
Participants are monitored after surgery to assess recovery and progression of tricuspid regurgitation through echocardiography at discharge and over time.
Follow-up visits at discharge, 1 year, 5 years, and 10 years after surgery
Trial Site Locations
Total: 3 locations
1
Istituto Clinico Humanitas
Rozzano, Milano, Italy, 20089
Actively Recruiting
2
IRCCS Ospedale San Raffaele
Milan, Italy, 20132
Actively Recruiting
3
Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland
Warsaw, Poland, 02-507
Actively Recruiting
Research Team
M
Michele De Bonis, MD,FESC,FAHA
C
Cinzia Trumello, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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