Clinical trial NCT03129737: PROphylactic triCuspID Annuloplasty in Patients With Dilated Tricuspid Annulus
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tricuspid (Valve) Insufficiency (Rheumatic)
Lead sponsor: Ettore Sansavini Health Science Foundation
Sponsor class: OTHER
First posted: 2017-04-26
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Progression of TR
timeFrame: 1 year
Secondary outcomes:
measure: Evaluation of reverse right ventricle (RV) remodelling
timeFrame: 1 year
measure: Residual TR
timeFrame: 1 year
Other outcomes:
measure: NYHA Class
timeFrame: 1 year
Locations:
city: Mercogliano
country: Italy
facility: Casa di Cura Montevergine
state: Avellino
city: Rapallo
country: Italy
facility: ICLAS
state: Genova
city: Cotignola
country: Italy
facility: Maria Cecilia Hospital
state: Ravenna
city: Bari
country: Italy
facility: Anthea Hospital
city: Bari
country: Italy
facility: Ospedale Santa Maria
city: Lecce
country: Italy
facility: Città di Lecce Hospital
city: Palermo
country: Italy
facility: Maria Eleonora Hospital
city: Torino
country: Italy
facility: Maria Pia Hospital
Study officials:
affiliation: Fondazione Ettore Sansavini per la Ricerca Scientifica ONLUS
name: Maria Salomone, MD
role: STUDY_DIRECTOR
References: