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.
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
200
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.
Casa di Cura Montevergine
Mercogliano, Avellino, Italy
NOT_YET_RECRUITINGICLAS
Rapallo, Genova, Italy
NOT_YET_RECRUITINGMaria Cecilia Hospital
Cotignola, Ravenna, Italy
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.
Time frame: 1 year
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
Time frame: 1 year
Residual TR
Percentage of patients with moderate to severe TR at one year after surgery
Time frame: 1 year
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Anthea Hospital
Bari, Italy
NOT_YET_RECRUITINGOspedale Santa Maria
Bari, Italy
NOT_YET_RECRUITINGCittà di Lecce Hospital
Lecce, Italy
RECRUITINGMaria Eleonora Hospital
Palermo, Italy
ACTIVE_NOT_RECRUITINGMaria Pia Hospital
Torino, Italy
NOT_YET_RECRUITING