NCT03227757

TRILUMINATE Study With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater TR

Trial to Evaluate Treatment With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater Tricuspid Regurgitation (TRILUMINATE)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to evaluate safety and effectiveness of the Tricuspid Valve Repair System (TVRS) for treating symptomatic moderate or greater tricuspid regurgitation (TR) in patients currently on medical management and who are deemed appropriate for percutaneous transcatheter intervention.

Detailed description

This is a prospective, single arm, multi-center study. A minimum of 85 subjects will be prospectively enrolled into this single arm study in approximately 25 sites, in Europe, Canada and the United States. Patients will be seen for follow-up visits at discharge (≤ 7 days post index procedure), 30 days, 6 months, 1,2,3 years.

Conditions

• Tricuspid Valve Insufficiency

Interventions

Type	Name	Description
DEVICE	Tricuspid Valve Repair System	Subjects who received TVRS will be included in this arm. The TVRS is intended for reconstruction of the insufficient tricuspid valve through tissue approximation.

Timeline

• Start date: 2017-08-01
• Primary completion: 2019-11-14
• Completion: 2024-05-30
• First posted: 2017-07-24
• Last updated: 2024-11-06
• Results posted: 2021-10-26

Locations

20 sites across 6 countries: United States, France, Germany, Italy, Spain, Switzerland

Regulatory

• FDA-regulated device study