Tricuspid Valve Insufficiency Clinical Trial
Official title:
Echo-Guided Tricuspid Valve Surgery Vs. Conservative Approach At The Time Of Left- Sided Valve Surgery. A Prospective Randomized Study
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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