NCT03278418

Echo-Guided Tricuspid Valve Surgery Vs. Conservative Approach

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 280 (estimated)
• Sponsor: Ettore Sansavini Health Science Foundation · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tricuspid Valve Insufficiency

Interventions

Type	Name	Description
PROCEDURE	Tricuspid Valve Repair	It will be performed according to the surgeon preference
PROCEDURE	Left-sided valve surgery	It will be performed according to the surgeon preference

Timeline

• Start date: 2017-09-01
• Primary completion: 2021-09-01
• Completion: 2021-10-01
• First posted: 2017-09-11
• Last updated: 2017-09-11

Locations

4 sites across 1 country: Italy