TriClip Japan Post-Approval Study

NCT07509658 · tracked via the Priya Life Science Japan tracker

Sponsor

Abbott Medical Devices

Phase

Observational

Started

2026-03-02

Last updated

2026-04-03

Condition(s) studied

Tricuspid Regurgitation

Investigational drug(s) / intervention(s)

The TriClip System

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

Study 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

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

Inclusion Criteria: * 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 Criteria: * There are no exclusion criteria * Please note: It is not recommended that subjects enrolled in the study participate in any other therapeutic clinical study.

Primary outcome measure(s)

Moderate or less Tricuspid Regurgitation (TR) at 30-day visit — 30 days
TR grade, defined as the proportion of subjects with TR severity classified as moderate or less, will be evaluated at the 30-day follow-up visit
Single Leaflet Device Attachment (SLDA) at 30-day visit — 30 days
SLDA rate, defined as the proportion of subjects with SLDA, will be evaluated at 30-day follow-up visit

Trial sites (1)

Facility	City	Region	Status
National Cerebral & Cardiovascular Center Hospital	Suita	Osaka	Recruiting

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A Clinical Evaluation of AMJ-401 Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07509658 on ClinicalTrials.gov ↗ ← All trials in Japan