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TriClip Japan Post-Approval Study
Sponsor: Abbott Medical Devices
Summary
The goal of this observational post approval study is to confirm the safety and efficacy of the TriClip System when used in routine clinical practice in the Japanese population and to fulfill post-market requirements following commercial approval in Japan.
Official title: A Prospective, Single-arm, Multi-center, Observational, Post-approval Study Designed to Confirm the Safety and Efficacy of the TriClip System in Japan.
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
250
Start Date
2026-03-02
Completion Date
2029-12-15
Last Updated
2026-04-03
Healthy Volunteers
No
Conditions
Interventions
The TriClip System
The TriClip System procedure will be performed in accordance with the Indication for Use (IFU) in Japan. The TriClip System is a transcatheter tricuspid valve repair system used to facilitate transcatheter edge-to-edge repair of the tricuspid valve leaflets and designed to deliver and deploy the Clip
Locations (1)
National Cerebral & Cardiovascular Center Hospital
Suita, Osaka, Japan