PROphylactic triCuspID Annuloplasty in Patients With Dilated Tricuspid Annulus
PROphylactic triCuspID Annuloplasty in Patients With Dilated Tricuspid Annulus
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)