RecruitingNot Applicable

TriClip Japan Post-Approval Study

Japan250 participantsStarted 2026-03-02

Plain-language 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.

Who can participate

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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

Timeframe: 30 days

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

Timeframe: 30 days

Trial details

NCT IDNCT07509658

SponsorAbbott Medical Devices

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2027-02-28

Contact for this trial

Jacob Zbinden

+16517564272 jacob.zbinden@abbott.com

View on ClinicalTrials.gov More Tricuspid Regurgitation trials