NCT04936802

Safety and Feasibility of the Transcatheter Tricuspid Valve Repair System (Trialign)

Safety and Feasibility of the Transcatheter Tricuspid Valve Repair System (Trialign) for the Treatment or Reduction of Moderate to Severe Functional Tricuspid Regurgitation

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (estimated)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to demonstrate safety and feasibility of the transcatheter tricuspid valve repair system (Trialign) for the treatment or reduction of moderate to severe functional tricuspid regurgitation.

Detailed description

This study is a prospective single-arm trial for transcatheter tricuspid valve repair system (Trialign). A series of physical, imaging and laboratory exams will be performed to determine whether a subject has moderate to severe tricuspid regurgitation with high surgical risk. Subjects who meet the criteria will then receiveTrialign treatment if an informed consent is obtained.

Conditions

• Tricuspid Regurgitation

Interventions

Type	Name	Description
DEVICE	Transcatheter tricuspid valve repair system (Trialign)	To assess the Trialign System to treat subjects with moderate to severe tricuspid regurgitation

Timeline

• Start date: 2021-06-25
• Primary completion: 2022-06-30
• Completion: 2023-06-30
• First posted: 2021-06-23
• Last updated: 2021-06-23