Tricuspid (Valve) Insufficiency (Rheumatic)
Conditions
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.
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.
Interventions
PROCEDUREMitral 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.
PROCEDURETricuspid 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.
Sponsors
Ettore Sansavini Health Science Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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: 1. Written informed consent 2. Degenerative mitral valve disease 3. \> 18 years old
Exclusion criteria
Main
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression of TR | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of reverse right ventricle (RV) remodelling | 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 |
| Residual TR | 1 year | Percentage of patients with moderate to severe TR at one year after surgery |
Other
| Measure | Time frame | Description |
|---|---|---|
| NYHA Class | 1 year | Modification of NYHA class at one year after surgery |
Countries
Italy
Contacts
Primary ContactKhalil Fattouch, MD
Backup ContactMaria Salomone, MD
Outcome results
None listed