Tricuspid Valve Insufficiency
Conditions
Brief summary
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
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.
Interventions
PROCEDURETricuspid Valve Repair
It will be performed according to the surgeon preference
PROCEDURELeft-sided valve surgery
It will be performed according to the surgeon preference
Sponsors
Ettore Sansavini Health Science Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Significant TR (moderate or severe) | 3 years | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mild TR | 1,2 and 3 years | 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). |
| Overall TR (mild, moderate, severe) | 1, 2 and 3 years | 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). |
| Significant TR (moderate or severe) | 1 and 2 years | 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). |
| Pulmonary Artery Pressure (PAP) | 1, 2 and 3 years | To compare the effect of the 2 strategies for non-severe TR on pulmonary artery pressure (PAP) |
| Event free survival | 3 years | 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 |
| RV function | 1, 2 and 3 years | 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. |
Countries
Italy
Contacts
Primary ContactMauro Del Giglio, MD
Backup ContactDonato Mele, MD
Outcome results
None listed