PROphylactic triCuspID Annuloplasty in Patients With Dilated Tricuspid Annulus
NCT ID: NCT03129737
Last Updated: 2017-06-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
2017-05-17
2020-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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 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.
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 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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
1. Written informed consent
2. Degenerative mitral valve disease
3. \> 18 years old
Exclusion Criteria
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)
18 Years
ALL
No
Sponsors
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Ettore Sansavini Health Science Foundation
OTHER
Responsible Party
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Principal Investigators
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Maria Salomone, MD
Role: STUDY_DIRECTOR
Fondazione Ettore Sansavini per la Ricerca Scientifica ONLUS
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Carlo Zebele, MD
Role: primary
Role: backup
Luigi Martinelli, MD
Role: primary
Role: backup
Mauro Del Giglio, MD
Role: primary
Role: backup
Giuseppe Speziale, MD,PhD
Role: primary
Role: backup
Domenico Paparella, MD, PhD
Role: primary
Role: backup
Renato Gregorini, MD
Role: primary
Role: backup
Chiara Comoglio, MD
Role: primary
Role: backup
Other Identifiers
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ESREFO 18
Identifier Type: -
Identifier Source: org_study_id
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