PROphylactic triCuspID Annuloplasty in Patients With Dilated Tricuspid Annulus

Not Applicable

• Conditions: Tricuspid (Valve) Insufficiency (Rheumatic)

• Registration Number: NCT03129737
• Lead Sponsor: Ettore Sansavini Health Science Foundation

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.

Study Timeline

• Study First Submitted: 2017-04-18
• Study First Submitted QC: 2017-04-21
• Study First Posted: 2017-04-26
• Study Start: 2017-05-17
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-27
• Last Update Posted: 2017-06-28
• Primary Completion: 2020-02
• Study Completion: 2020-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Progression of TR	1 year	Progression of TR at one year follow-up defined as worsening of at least one class with respect to pre-surgery as assessed by the Core lab evaluation of the echocardiogram.

Secondary Outcome Measures

Name	Time	Method
Evaluation of reverse right ventricle (RV) remodelling	1 year	The evaluation of reverse right ventricle (RV) remodelling, assessed as reduction/modification of the end diastolic and end systolic RV diameters with respect to pre-surgery
Residual TR	1 year	Percentage of patients with moderate to severe TR at one year after surgery

Trial Locations

Locations (8)

Casa di Cura Montevergine; 🇮🇹 Mercogliano, Avellino, Italy

ICLAS; 🇮🇹 Rapallo, Genova, Italy

Maria Cecilia Hospital; 🇮🇹 Cotignola, Ravenna, Italy

Anthea Hospital; 🇮🇹 Bari, Italy

Ospedale Santa Maria; 🇮🇹 Bari, Italy

Città di Lecce Hospital; 🇮🇹 Lecce, Italy

Maria Eleonora Hospital; 🇮🇹 Palermo, Italy

Maria Pia Hospital; 🇮🇹 Torino, Italy