TriClip Japan Post-Approval Study

ConditionTricuspid Regurgitation

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

AgeNot listed

SponsorAbbott Medical Devices

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

There are no exclusion criteria

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

Trial 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.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

The TriClip System
Device
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

Treatment groups

250 Participants

are divided into 1 treatment group

Group A: Subjects who receive TriClip procedure with TriClip System1 intervention

Trial outcomes

Primary outcomes

Moderate or less Tricuspid Regurgitation (TR) at 30-day visit

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

Time frame

30 days

Single Leaflet Device Attachment (SLDA) at 30-day visit

SLDA rate, defined as the proportion of subjects with SLDA, will be evaluated at 30-day follow-up visit

Time frame

30 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Abbott Medical Devices

Lead sponsor

Source ClinicalTrials.gov

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