Echo-Guided Tricuspid Valve Surgery Vs. Conservative Approach At The Time Of Left- Sided Valve Surgery. A Prospective Randomized Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Tricuspid Valve Insufficiency
- Sponsor
- Ettore Sansavini Health Science Foundation
- Enrollment
- 280
- Locations
- 4
- Primary Endpoint
- Significant TR (moderate or severe)
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Significant TR (moderate or severe)
Time Frame: 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 Outcomes
- Significant TR (moderate or severe)(1 and 2 years)
- Overall TR (mild, moderate, severe)(1, 2 and 3 years)
- Event free survival(3 years)
- Mild TR(1,2 and 3 years)
- RV function(1, 2 and 3 years)
- Pulmonary Artery Pressure (PAP)(1, 2 and 3 years)