RecruitingNCT07509658

TriClip Japan Post-Approval Study

A Prospective, Single-arm, Multi-center, Observational, Post-approval Study Designed to Confirm the Safety and Efficacy of the TriClip System in Japan.

Sponsor

Abbott Medical Devices

Enrollment

250 participants

Start Date

Mar 2, 2026

Study Type

OBSERVATIONAL

Conditions

Tricuspid Regurgitation

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.

Eligibility

Inclusion Criteria2

Subjects are eligible to receive the TriClip System per the current approved indications for use (IFU)
Subjects provide written informed consent prior to conducting any investigation-specific procedures not considered standard of care.

Exclusion Criteria1

Please note: It is not recommended that subjects enrolled in the study participate in any other therapeutic clinical study.

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Interventions

DEVICEThe 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