An interventional study of Mitral valve surgery and Tricuspid valve annuloplasty in Tricuspid (Valve) Insufficiency (Rheumatic), sponsored by Ettore Sansavini Health Science Foundation. Status unknown at 8 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-06-28.
Sponsored by Ettore Sansavini Health Science Foundation · Not applicable, Interventional, and Prevention
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.
225 studies on the registry are indexed under Tricuspid Valve Insufficiency; 108 are open to participants now.
This study's planned enrollment of 200 is above the median of 60 across 124 interventional studies indexed under Tricuspid Valve Insufficiency.
Browse Tricuspid Valve Insufficiency studies →Ettore Sansavini Health Science Foundation is the lead sponsor of 9 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
Exclusion Criteria:
Main exclusion criteria:
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 · Procedure: Tricuspid valve annuloplasty
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.
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.
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
NYHA Class
Modification of NYHA class at one year after surgery
Time frame: 1 year
Plan to share: No
No publications or documents are linked to this record.
Started May 2017 (actual). Primary completion is estimated for Feb 2020, 33 months after the start.
Of 83 interventional studies with no phase under Tricuspid Valve Insufficiency, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 58. This study's planned 33 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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Ettore Sansavini Health Science Foundation