- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03129737
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
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
-
-
-
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
Accepts Healthy Volunteers
Genders Eligible for Study
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:
- Written informed consent
- Degenerative mitral valve disease
- > 18 years old
Exclusion Criteria:
Main exclusion criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
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
|
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.
|
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
|
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
Time Frame: 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.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of reverse right ventricle (RV) remodelling
Time Frame: 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
|
1 year
|
Residual TR
Time Frame: 1 year
|
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
Time Frame: 1 year
|
Modification of NYHA class at one year after surgery
|
1 year
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ESREFO 18
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Tricuspid (Valve) Insufficiency (Rheumatic)
-
Medical College of WisconsinChildren's Hospital and Health System Foundation, WisconsinCompletedMitral Valve Regurgitation | Tricuspid Valve Regurgitation, Non-rheumaticUnited States
-
Edwards LifesciencesActive, not recruitingTricuspid Regurgitation | Tricuspid InsufficiencyGermany, Spain, Switzerland
-
VDyne, Inc.RecruitingTricuspid Regurgitation | Tricuspid Valve Disease | Tricuspid Valvular DisordersAustralia, Czechia, Austria
-
Azienda Ospedaliero, Universitaria PisanaNot yet recruitingSevere Tricuspid Valve Regurgitation
-
CroiValve LimitedRecruitingHeart Valve Diseases | Tricuspid Valve Insufficiency | Tricuspid Regurgitation | Tricuspid Valve DiseaseUnited States
-
Baylor Research InstituteTerminatedTricuspid Regurgitation | Tricuspid Valve DiseaseUnited States
-
VDyne, Inc.Not yet recruitingTricuspid Regurgitation | Tricuspid Valve Disease | Tricuspid Valvular DisordersUnited States
-
P+F Products + Features GmbHMeditrial USA Inc.Not yet recruitingTricuspid Regurgitation | Tricuspid Valve DiseaseUnited States
-
Michele De BonisCompleted
-
P+F Products + Features GmbHRecruitingHeart Diseases | Heart Failure | Heart Valve Diseases | Tricuspid Valve Insufficiency | Tricuspid Regurgitation | Tricuspid InsufficiencySpain, Germany, Austria, Belgium, Lithuania
Clinical Trials on Mitral valve surgery
-
Guy's and St Thomas' NHS Foundation TrustKing's College Hospital NHS Trust; Royal Brompton & Harefield NHS Foundation... and other collaboratorsNot yet recruitingMitral Regurgitation
-
Michele De BonisCompletedMitral Regurgitation | Aortic RegurgitationItaly
-
Meshalkin Research Institute of Pathology of CirculationCompletedHypertrophic Obstructive CardiomyopathyRussian Federation
-
University Hospital, Basel, SwitzerlandRecruitingMitral Valve Disease | Mitral Valve SurgerySwitzerland
-
Karolinska InstitutetKarolinska University HospitalRecruitingMitral Regurgitation | Surgery | Mitral Valve Prolapse | Ventricular Arrythmia | Mitral Annular DisjunctionSweden
-
University Hospital, Basel, SwitzerlandWithdrawn
-
Atlantic Health SystemUnknownMitral Valve InsufficiencyUnited States
-
University of Turin, ItalyUnknownMitral Valve Insufficiency | Neurological ComplicationsItaly
-
Instituto Dante Pazzanese de CardiologiaEdwards LifesciencesRecruitingMitral Prosthetic Valve Stenosis and RegurgitationBrazil
-
University of Maryland, BaltimoreEdwards LifesciencesCompletedCardiac Surgery | Tricuspid Valve RegurgitationUnited States