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Patients elected to undergo any type of left-sided valve surgery (either repair or replacement) with non severe tricuspid regurgitation and tricuspid annular dilation will be screened. Consenting patients fulfilling all inclusion and exclusion criteria will be included in the study and assigned to elective left-sided valve replacement or repair with or without concomitant tricuspid valve repair 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 70 patients over a 12 months enrolment period.
Patients elected to undergo any type of left-sided valve surgery (either repair or replacement) with non severe tricuspid regurgitation and tricuspid annular dilation will be screened. Consenting patients fulfilling all inclusion and exclusion criteria will be included in the study and assigned to elective left-sided valve replacement or repair with or without concomitant tricuspid valve repair in a 1:1 fashion, using a blocked randomization scheme balanced within center.
After discharge patients will be assessed at 1, 12, 24 and 36 months after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tricuspid Valve Repair | Experimental | Concomitant tricuspid valve repair in patients undergoing left-sided valve surgery |
|
| left-sided valve surgery | Active Comparator | No concomitant tricuspid valve repair in patients in pts undergoing left-sided valve surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tricuspid Valve Repair | Procedure | It will be performed according to the surgeon preference |
|
| Measure | Description | Time Frame |
|---|---|---|
| Significant TR (moderate or severe) | To compare in a prospective and randomized way the effect of two different strategies on significant TR (moderate or severe) in patients undergoing surgery for left heart valve disease of any type as assessed by the Core lab evaluation of the echocardiogram. In the echocardiogram images TR by jet area will be grouped as moderate (5-10 cm2) or severe (>10 cm2). | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Significant TR (moderate or severe) | To compare in a prospective and randomized way the effect of two different strategies on significant TR (moderate or severe) in patients undergoing surgery for left heart valve disease of any type as assessed by the Core lab evaluation of the echocardiogram. In the echocardiogram images TR by jet area will be grouped as moderate (5-10 cm2) or severe (>10 cm2). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mauro Del Giglio, MD | Contact | +390545217445 | mdelgiglio@gvmnet.it | |
| Donato Mele, MD | Contact | +393476411190 | donatomele@libero.it |
| Name | Affiliation | Role |
|---|---|---|
| Maria Salomone, MD | Fondazione Ettore Sansavini per la Ricerca Scientifica ONLUS | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maria Cecilia Hospital | Cotignola | Ravenna | 48033 | Italy | ||
| IRCCS Policlinico San Donato |
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| ID | Term |
|---|---|
| D014262 | Tricuspid Valve Insufficiency |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Left-sided valve surgery | Procedure | It will be performed according to the surgeon preference |
|
| 1 and 2 years |
| Mild TR | To compare in a prospective and randomized way the effect of two different strategies on significant TR (moderate or severe) in patients undergoing surgery for left heart valve disease of any type as assessed by the Core lab evaluation of the echocardiogram. In the echocardiogram images TR by jet area will be grouped as non severe (≤10 cm2) or mild (<5 cm2). | 1,2 and 3 years |
| Overall TR (mild, moderate, severe) | To compare in a prospective and randomized way the effect of two different strategies on significant TR (moderate or severe) in patients undergoing surgery for left heart valve disease of any type as assessed by the Core lab evaluation of the echocardiogram. In the echocardiogram images TR by jet area will be grouped as non severe (≤10 cm2; mild <5 cm2, moderate = 5-10 cm2), or severe (>10 cm2). | 1, 2 and 3 years |
| RV function | To compare the effect of the 2 strategies for non-severe TR described above on the evaluation of reverse right ventricle (RV) remodelling, assessed as reduction/modification of the end diastolic and end systolic RV diameters. | 1, 2 and 3 years |
| Pulmonary Artery Pressure (PAP) | To compare the effect of the 2 strategies for non-severe TR on pulmonary artery pressure (PAP) | 1, 2 and 3 years |
| Event free survival | Safety evaluation will rely on all AE/SAEs subsequent to spontaneous reporting, or to detection of clinically relevant abnormalities on physical examinations, vital signs, ECG, and laboratory tests | 3 years |
| Milan |
| 20097 |
| Italy |
|
| IRCCS Opsedale San Raffaele | Milan | 20132 | Italy |
|
| Maria Eleonora Hospital | Palermo | 90135 | Italy |
|