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
1 other identifier
interventional
200
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2017
Typical duration for not_applicable
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 18, 2017
CompletedFirst Posted
Study publicly available on registry
April 26, 2017
CompletedStudy Start
First participant enrolled
May 17, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedJune 28, 2017
June 1, 2017
2.7 years
April 18, 2017
June 27, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Evaluation of reverse right ventricle (RV) remodelling
1 year
Residual TR
1 year
Other Outcomes (1)
NYHA Class
1 year
Study Arms (2)
Tricuspid valve annuloplasty
EXPERIMENTALConcomitant tricuspid valve annuloplasty in patients with tricuspid annulus dilatation (\>21mm /m2) with or without TR≤ moderate in pts undergoing mitral valve surgery
Mitral valve repair
ACTIVE COMPARATORNo concomitant tricuspid valve annuloplasty in patients with tricuspid annulus dilatation (\>21mm/m2) with or without TR ≤ moderate in pts undergoing mitral valve surgery
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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:
- Written informed consent
- Degenerative mitral valve disease
- \> 18 years old
You may not qualify if:
- Presence of structural or organic tricuspid valve disease
- urgent operation
- presence of pacemaker leads through the tricuspid annulus
- acute endocarditis or other organic valve diseases
- previous surgical procedure
- Severe TR
- Associated cardiac procedure
- NYHA class IV
- Severe COPD (GOLD class 3,4)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Casa di Cura Montevergine
Mercogliano, Avellino, 83013, Italy
ICLAS
Rapallo, Genova, 16035, Italy
Maria Cecilia Hospital
Cotignola, Ravenna, 48033, Italy
Anthea Hospital
Bari, 70124, Italy
Ospedale Santa Maria
Bari, 70124, Italy
Città di Lecce Hospital
Lecce, 73100, Italy
Maria Eleonora Hospital
Palermo, 90135, Italy
Maria Pia Hospital
Torino, 10132, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Maria Salomone, MD
Fondazione Ettore Sansavini per la Ricerca Scientifica ONLUS
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 18, 2017
First Posted
April 26, 2017
Study Start
May 17, 2017
Primary Completion
February 1, 2020
Study Completion
June 1, 2020
Last Updated
June 28, 2017
Record last verified: 2017-06
Data Sharing
- IPD Sharing
- Will not share