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

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

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.

Study Overview

• Status: Unknown
• Conditions: Tricuspid (Valve) Insufficiency (Rheumatic)
• Intervention / Treatment: Procedure: Mitral valve surgery; Procedure: Tricuspid valve annuloplasty

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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Khalil Fattouch, MD; Phone Number: +39 328 8105584; Email: khalilfattouch@hotmail.com
• Study Contact Backup: Name: Maria Salomone, MD; Phone Number: +39 389 5635731; Email: msalomone@esrefo.org

Study Locations

• Italy
  • Bari, Italy, 70124
    • Not yet recruiting
    • Anthea Hospital
    • Contact: Giuseppe Speziale, MD,PhD
    • Contact: Email: gspeziale@gvmnet.it
  • Bari, Italy, 70124
    • Not yet recruiting
    • Ospedale Santa Maria
    • Contact: Domenico Paparella, MD, PhD
    • Contact: Email: domenico.paparella@uniba.it
  • Lecce, Italy, 73100
    • Recruiting
    • Città di Lecce Hospital
    • Contact: Renato Gregorini, MD
    • Contact: Email: re.greg@tin.it
  • Palermo, Italy, 90135
    • Active, not recruiting
    • Maria Eleonora Hospital
  • Torino, Italy, 10132
    • Not yet recruiting
    • Maria Pia Hospital
    • Contact: Chiara Comoglio, MD
    • Contact: Email: chiaracomoglio@gmail.com
  • Avellino
    • Mercogliano, Avellino, Italy, 83013
      • Not yet recruiting
      • Casa di Cura Montevergine
      • Contact: Carlo Zebele, MD
      • Contact: Email: carlo.zebele@gmail.com
  • Genova
    • Rapallo, Genova, Italy, 16035
      • Not yet recruiting
      • ICLAS
      • Contact: Luigi Martinelli, MD
      • Contact: Email: lumartinelli49@virgilio.it
  • Ravenna
    • Cotignola, Ravenna, Italy, 48033
      • Recruiting
      • Maria Cecilia Hospital
      • Contact: Mauro Del Giglio, MD
      • Contact: Email: mdelgiglio@gvmnet.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tricuspid valve annuloplasty; Concomitant tricuspid valve annuloplasty in patients with tricuspid annulus dilatation (>21mm /m2) with or without TR≤ moderate in pts undergoing mitral valve surgery	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.; Procedure: 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.
Active Comparator: Mitral valve repair; No concomitant tricuspid valve annuloplasty in patients with tricuspid annulus dilatation (>21mm/m2) with or without TR ≤ moderate in pts undergoing mitral valve surgery	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Residual TR	Percentage of patients with moderate to severe TR at one year after surgery	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
NYHA Class	Modification of NYHA class at one year after surgery	1 year

Collaborators and Investigators

• Sponsor: Ettore Sansavini Health Science Foundation

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2017
• Primary Completion (Anticipated): February 1, 2020
• Study Completion (Anticipated): June 1, 2020

Study Registration Dates

• First Submitted: April 18, 2017
• First Submitted That Met QC Criteria: April 21, 2017
• First Posted (Actual): April 26, 2017

Study Record Updates

• Last Update Posted (Actual): June 28, 2017
• Last Update Submitted That Met QC Criteria: June 27, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Connective Tissue Diseases; Rheumatic Diseases
• Other Study ID Numbers: ESREFO 18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No