PROphylactic triCuspID Annuloplasty in Patients With Dilated Tricuspid Annulus

Tricuspid (Valve) Insufficiency (Rheumatic) Clinical Trial

— PROCIDA  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03129737
• Other study ID #: ESREFO 18
• Status: Recruiting
• Phase: N/A
• First received: April 18, 2017
• Last updated: June 27, 2017
• Start date: May 17, 2017
• Est. completion date: June 2020

Study information

• Verified date: June 2017
• Source: Ettore Sansavini Health Science Foundation
• Contact: Khalil Fattouch, MD
• Phone: +39 328 8105584
• Email: khalilfattouch[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 2020
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Tricuspid (Valve) Insufficiency (Rheumatic)

Intervention

Procedure:
• Mitral valve surgery
Mitral valve repair is preferred whenever technically feasible over valve replacement. Annuloplasty may be used as sole therapy or in conjunction with other repair maneuvers to support the reconstruction and reinforce the annulus as well as prevent future annular dilatation. The mitral regurgitation secondary to myxomatous degeneration is prolapse of the middle scallop of the posterior leaflet result from chordal rupture or chordal elongation. Quadrangular resection of the involved middle scallop of the posterior leaflet combined with a posterior mitral annuloplasty is the best way to handle this situation. Chordae replacement could be used also to treat flail/prolapse of the anterior leaflet. Annuloplasty is always doing in mitral valve repair to stabilize and reshape the annulus.
• Tricuspid valve annuloplasty
Depending on the extent of the valve disease, there is the possibility to perform valve repair. In mitral valve reference center the rate of repair will reach 100%. In many patients with mitral valve regurgitation, tricuspid valve will be insufficient or the annulus dilated. Tricuspid annuloplasty ring will be helpful to treat dilation by reshaping, or to treat the regurgitant diseases. The ring will be secured and sutured to the native annulus by U-stitches.

Locations

Country	Name	City	State
Italy	Anthea Hospital	Bari
Italy	Ospedale Santa Maria	Bari
Italy	Maria Cecilia Hospital	Cotignola	Ravenna
Italy	Città di Lecce Hospital	Lecce
Italy	Casa di Cura Montevergine	Mercogliano	Avellino
Italy	Maria Eleonora Hospital	Palermo
Italy	ICLAS	Rapallo	Genova
Italy	Maria Pia Hospital	Torino

Sponsors (1)

Lead Sponsor	Collaborator
Ettore Sansavini Health Science Foundation

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	NYHA Class	Modification of NYHA class at one year after surgery	1 year
Primary	Progression of TR	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.	1 year
Secondary	Evaluation of reverse right ventricle (RV) remodelling	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	1 year
Secondary	Residual TR	Percentage of patients with moderate to severe TR at one year after surgery	1 year