Echo-Guided Tricuspid Valve Surgery Vs. Conservative Approach

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Echo-Guided Tricuspid Valve Surgery Vs. Conservative Approach At The Time Of Left- Sided Valve Surgery. A Prospective Randomized Study

Conditions
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Tricuspid Valve Insufficiency

Intervention / Treatment
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* Procedure: Tricuspid Valve Repair
* Procedure: Left-sided valve surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing left-sided valve surgery for left-sided valve disease Presence of non-severe TR and tricuspid annular dilation (>40 mm or > 21 mm/m2 BSA) determined by echocardiography Age ≥ 18 years Capability to sign Informed Consent and Release of Medical Information forms Exclusion Criteria: Preoperative severe TR Structural / organic tricuspid valve disease Tricuspid annulus ≤40 mm (or ≤ 21 mm/m2 BSA) on preoperative TTE Implanted pacemaker or defibrillator, where the leads cross the tricuspid valve from the right atrium into the RV Any type of reoperative surgery Concomitant cardiac surgery other than atrial fibrillation correction surgery (pulmonary vein isolation, Maze procedure, left atrial appendage closure) or closure of patent foramen ovale or atrial septal defect (for example, concomitant coronary artery bypass graft or aortic surgery) Cardiogenic shock at the time of randomization ST-elevated myocardial infarction requiring intervention within 7 days prior to randomization Evidence of cirrhosis or hepatic synthetic failure Severe, irreversible pulmonary hypertension in the judgment of the investigator Pregnancy at the time of randomization Any concurrent disease with life expectancy < 1 year Patient unable or unwilling to provide informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tricuspid Valve Repair<br>Concomitant tricuspid valve repair in patients undergoing left-sided valve surgery | Procedure: Tricuspid Valve Repair<br>* It will be performed according to the surgeon preference<br>Procedure: Left-sided valve surgery<br>* It will be performed according to the surgeon preference<br>|
| Active Comparator: left-sided valve surgery<br>No concomitant tricuspid valve repair in patients in pts undergoing left-sided valve surgery | Procedure: Left-sided valve surgery<br>* It will be performed according to the surgeon preference<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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). | 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 |