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

Launched by OSPEDALE SAN RAFFAELE · Dec 14, 2016

Keywords

ClinConnect Summary

The NOSTRUM trial is studying whether adding a procedure called tricuspid annuloplasty (which helps fix a specific heart valve problem) during mitral valve surgery is beneficial for patients who have mild tricuspid regurgitation (TR). TR is when the heart's tricuspid valve doesn't close properly, causing some blood to flow backward. The trial aims to find out if doing both surgeries at the same time can prevent worsening of TR over the next year, compared to just fixing the mitral valve alone.

To participate in this trial, patients need to be at least 18 years old and scheduled for surgery to fix their mitral valve due to regurgitation. They should also have mild TR and a dilated tricuspid valve. Participants will be randomly assigned to either have only the mitral valve repaired or to have both the mitral and tricuspid valves repaired. Throughout the study, researchers will carefully monitor how well the surgeries work and if patients experience any improvements in their condition. This trial is important as it seeks to provide clearer answers about the best approach for patients with this type of heart issue.

Gender

ALL

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