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

Ettore Sansavini Health Science Foundation

Status: Unknown

Conditions: Tricuspid (Valve) Insufficiency (Rheumatic)

Treatments: Procedure: Tricuspid valve annuloplasty; Procedure: Mitral valve surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT03129737

ESREFO 18

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Tricuspid valve annuloplasty

Experimental group

Description:

Concomitant tricuspid valve annuloplasty in patients with tricuspid annulus dilatation (\>21mm /m2) with or without TR≤ moderate in pts undergoing mitral valve surgery

Treatment:

Procedure: Tricuspid valve annuloplasty

Procedure: Mitral valve surgery

Mitral valve repair

Active Comparator group

Description:

No concomitant tricuspid valve annuloplasty in patients with tricuspid annulus dilatation (\>21mm/m2) with or without TR ≤ moderate in pts undergoing mitral valve surgery

Treatment:

Procedure: Mitral valve surgery