TriClip Japan Post-Approval Study (TriClip JP PAS)

March 31, 2026 updated by: Abbott Medical Devices

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Tricuspid Regurgitation (TR) is an abnormal condition which has both short-term and long-term consequences. TR decreases forward cardiac output and raises right-sided systemic venous pressures. This physiology will often result in hepatorenal congestion and dysfunction and, in addition, cause edema and ascites. The retrograde cardiac blood flow and volume loading also leads to further tricuspid dilatation exacerbating regurgitation over time.

The TriClip System is indicated for TR reduction in patients with symptomatic severe tricuspid regurgitation despite optimal medical therapy, who are under the following conditions, as determined by a heart team:

  • Patients with left-sided disease must be well treated according to the Japan guideline
  • Patients for whom tricuspid valve surgery is not the optimal treatment
  • Patients in whom transcatheter edge-to-edge valve repair is clinically appropriate

The objective of the TriClip Japan post-approval study is to confirm the safety and efficacy of the TriClip System for the treatment of symptomatic severe tricuspid regurgitation in a contemporary, real-world setting in the Japanese population, using the commercially available device in accordance with its approved indications for use.

Study Type

Observational

Enrollment (Estimated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Japan
    • Osaka
      • Suita, Osaka, Japan, 564-8565
        • Recruiting
        • National Cerebral & Cardiovascular Center Hospital
        • Contact:
          • Chisato Izumi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This observational post-approval study will enroll subjects from the general Japanese population who are scheduled to undergo the TriClip procedure per the current Japan IFU.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Subjects who receive TriClip procedure with TriClip System
The subjects from the general Japanese population are scheduled to undergo the TriClip procedure with commercially approved TriClip System per the current Japan Indication for Use (IFU).
Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Moderate or less Tricuspid Regurgitation (TR) at 30-day visit
Time Frame: 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
30 days
Single Leaflet Device Attachment (SLDA) at 30-day visit
Time Frame: 30 days
SLDA rate, defined as the proportion of subjects with SLDA, will be evaluated at 30-day follow-up visit
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2026

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

December 15, 2029

Study Registration Dates

First Submitted

March 23, 2026

First Submitted That Met QC Criteria

March 31, 2026

First Posted (Actual)

April 3, 2026

Study Record Updates

Last Update Posted (Actual)

April 3, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABT-CIP-10613

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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