NCT04339192

Minimally Invasive Tricuspid Surgery vs Medical Treatment for Severe TR

Minimally Invasive Tricuspid Surgery Versus Medical Treatment for Severe Tricuspid Regurgitation After Left-sided Valve Surgery

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 330 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Late tricuspid regurgitation (TR) is a common complication after left-sided valve surgery (LSVS), which usually progresses slowly and results in right heart failure at terminal stage. Over the past 3 decades, with the advances in minimally invasive surgical techniques, operative mortality after reoperation for severe TR has significantly decreased from 30% to 3-8%, leading to a gradual shift from medical therapy alone to surgery in those patients. However, there has been no consensus on the clinical benefit of minimally invasive tricuspid surgery over medical therapy for severe TR after LSVS.

Detailed description

In this multi-center randomized controlled trial, patients with severe TR after LSVS will be recruited. The patients will be randomly assigned to surgery plus medical therapy (surgery group) or medical therapy alone (control group). The primary outcome will be a composite of all-cause mortality, re-admission for right heart failure or the composite. Furthermore, echocardiography-based measurement of right heart function, New York Heart Association functional class, liver and kidney function, and quality of life will be compared between the 2 groups. All outcomes will be assessed at baseline and 6, 12 and 24 months after randomization.

Conditions

• Tricuspid Regurgitation

Interventions

Type	Name	Description
PROCEDURE	Minimally Invasive Tricuspid Surgery	minimally invasive tricuspid surgery including endoscopy-assist right minithoracotomy, vacuum-assist single femoral venous drainage without dissecting or snaring vena cava, direct right atriotomy through pericardium and the beating-heart technique.

Timeline

• Start date: 2020-05-01
• Primary completion: 2023-12-31
• Completion: 2024-06-01
• First posted: 2020-04-09
• Last updated: 2020-04-09

Locations

1 site across 1 country: China