TriClip for treating tricuspid regurgitation in Japan
A Prospective, Single-arm, Multi-center, Observational, Post-approval Study Designed to Confirm the Safety and Efficacy of the TriClip System in Japan.
This study will see if the TriClip device is safe and helps people in Japan with symptomatic severe tricuspid regurgitation when used in routine clinical care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Sex | All |
| Sponsor | Abbott Medical Devices Industry-sponsored |
| Locations | 1 site (Suita, Osaka) |
| Trial ID | NCT07509658 on ClinicalTrials.gov |
What this trial studies
The TriClip Japan post-approval observational registry will collect real-world safety and effectiveness data on the commercially available TriClip System used to reduce severe tricuspid regurgitation in Japanese patients. Eligible patients are treated per the device's approved instructions for use and are selected by a heart team, with no study-specific exclusion criteria beyond standard of care. Data on procedural outcomes, adverse events, symptom status, and device performance will be captured during routine follow-up to meet post-market regulatory requirements. The design reflects everyday clinical practice rather than randomized assignment, aiming to confirm device performance in a contemporary Japanese population.
Who should consider this trial
Good fit: Adults in Japan with symptomatic severe tricuspid regurgitation despite optimal medical therapy, judged by a heart team to be appropriate for transcatheter edge-to-edge repair and for whom surgery is not the best option, are eligible.
Not a fit: Patients with mild or asymptomatic tricuspid regurgitation, those who are good candidates for surgical repair or replacement, or patients with anatomy unsuitable for the device are unlikely to benefit.
Why it matters
Potential benefit: If successful, broader use of TriClip could reduce symptoms and hospitalizations related to right-sided heart failure and offer a less invasive option for patients who are not good surgical candidates.
How similar studies have performed: Prior trials and registries of transcatheter edge-to-edge tricuspid repair, including TRILUMINATE and several real-world registries, have reported promising reductions in regurgitation and symptom improvement, although long-term outcomes remain under study.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Suita, Osaka
- National Cerebral & Cardiovascular Center Hospital — Suita, Osaka, Japan (Recruiting)
Study contacts
- Study coordinator: Jacob Zbinden
- Email: jacob.zbinden@abbott.com
- Phone: +16517564272
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.