TriClip for treating tricuspid regurgitation in Japan
Official title: A Prospective, Single-arm, Multi-center, Observational, Post-approval Study Designed to Confirm the Safety and Efficacy of the TriClip System in Japan.
Run by Abbott Medical Devices · NCT07509658 · Data updated 2026-11-12
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 |
|---|---|
| Sex | All |
| Enrollment | 250 (estimated) |
| Sponsor | Abbott Medical Devices Industry-sponsored |
| Locations | 1 site (Suita, Osaka) |
| Status | Recruiting |
| Started | March 2, 2026 |
| Main results expected | February 28, 2027 |
| Study ends | December 15, 2029 |
| Registry record updated | April 3, 2026 |
| Trial ID | NCT07509658 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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National Cerebral & Cardiovascular Center Hospital
Suita, Osaka, Japan Recruiting
Study contacts
- Study coordinator: Jacob Zbinden
- Email: jacob.zbinden@abbott.com
- Phone: +16517564272
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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3D Echocardiography to See How CIEDs May Worsen Tricuspid Regurgitation
This study tests whether different CIEDs (leadless pacemakers, LBBaP, and conventional pacemakers) differ in causing worsening tricuspid regurgitation, using 3D heart imaging.
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This study will try catheter-based tricuspid valve repair (TEER) in older adults with severe symptomatic tricuspid regurgitation to see if kidney function, fluid overload, and physical activity improve.
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TARGET 2.0: Cardiovalve TR replacement for tricuspid regurgitation
This study will test a percutaneously delivered Cardiovalve tricuspid replacement via the femoral vein in adults with symptomatic severe secondary tricuspid regurgitation who are high risk for open-heart surgery.
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Pivot Extend device to treat severe tricuspid regurgitation
This trial will try the Pivot Extend device in adults with severe, symptomatic tricuspid regurgitation to see if it safely reduces valve leakage and improves symptoms.
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Early feasibility of the Laplace Transcatheter Tricuspid Valve Replacement — Canada
This study tries the Laplace transcatheter tricuspid valve replacement to see if it is safe and can be successfully implanted in people aged 60–90 with severe, symptomatic tricuspid regurgitation who remain symptomatic despite optimal medical therapy.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.