PROphylactic triCuspID Annuloplasty in Patients With Dilated Tricuspid Annulus

Multi-centre Randomised Trial Investigating the Effect of PROphylactic triCuspID Annuloplasty in Patients With Dilated Tricuspid Annulus on Tricuspid Regurgitation Progression, Right Ventricular Remodeling and Functional Outcomes

Patients elected to undergo mitral valve surgery (either repair or replacement) with less equal than moderate (≤+2) tricuspid regurgitation and dilated tricuspid annulus (>21mm/m2) at preoperative echocardiography will be screened. Consenting patients fulfilling all inclusion and exclusion criteria will be included in the study and assigned to elective mitral valve replacement or repair with or without concomitant tricuspid annuloplasty in a 1:1 fashion, using a blocked randomization scheme balanced within center.

The present study is designed as a prospective, multicentre, multinational, randomized, 2-arm parallel group trial. Participating centres are selected based on previous experience with the surgical technique and standardised echo imaging. Each center is expected to contribute 20 to 40 patients over a 12-month enrolment period.

Patients elected to undergo mitral valve surgery (either repair or replacement) with less equal than moderate (≤+2) tricuspid regurgitation and dilated tricuspid annulus (>21mm/m2) at preoperative echocardiography will be screened. Consenting patients fulfilling all inclusion and exclusion criteria will be included in the study and assigned to elective mitral valve replacement or repair with or without concomitant tricuspid annuloplasty in a 1:1 fashion, using a blocked randomization scheme balanced within center.

After discharge patients will be assessed at 1 month (phone contact), 6 month and 1-year after surgery.

Inclusion Criteria:

Patients undergoing mitral valve surgery (either repair or replacement) with less/equal than moderate (≤+2) tricuspid regurgitation and dilated tricuspid annulus (>21mm/m2 BSA) at preoperative echocardiography and fulfilling the following selection criteria:

Inclusion criteria:

1. Written informed consent
2. Degenerative mitral valve disease
3. > 18 years old

Exclusion Criteria:

Main exclusion criteria:

1. Presence of structural or organic tricuspid valve disease
2. urgent operation
3. presence of pacemaker leads through the tricuspid annulus
4. acute endocarditis or other organic valve diseases
5. previous surgical procedure
6. Severe TR
7. Associated cardiac procedure
8. NYHA class IV
9. Severe COPD (GOLD class 3,4)