Tricuspid RegurgitationTriClip JP PASNCT07509658
TriClip Japan Post-Approval Study
An observational study of Tricuspid Regurgitation, run by Abbott Medical Devices at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tricuspid Regurgitation
- What is being tested?
- The TriClip System
- Type of treatment
- Medical device
- How many people
- 250 participants
- Where
- 1 siteJapan
- Study dates
- 2 Mar 2026to 15 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Meghan Griffin contact
Japan1 site, 1 recruiting
- Recruiting
National Cerebral & Cardiovascular Center Hospital
Suita, Osaka, 564-8565
Chisato Izumi
About this study
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.
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.
Read the 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.
- Conditions
- Tricuspid Regurgitation
- Being tested
- The TriClip System
- Keywords
- TR, Tricuspid Regurgitation, TriClip
- Medical subject headings
- Tricuspid Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The TriClip SystemDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: The TriClip System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study start2 Mar 2026
- Primary completion28 Feb 2027 (estimated)
- Study completion15 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tricuspid RegurgitationStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07509658
- Sponsor's protocol ID
- ABT-CIP-10613
- Acronym
- TriClip JP PAS
- Status last verified
- Mar 2026
- First submitted
- 23 Mar 2026
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07509658
- Acronym / sponsor ID
- TriClip JP PAS / ABT-CIP-10613
- Conditions
- Tricuspid Regurgitation
- Keywords
- TR, Tricuspid Regurgitation, TriClip
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 2 Mar 2026 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 15 Dec 2029 (estimated)
- First posted
- 3 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects who receive TriClip procedure with TriClip System | – | Device: The TriClip SystemThe 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). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- There are no exclusion criteria
- Please note: It is not recommended that subjects enrolled in the study participate in any other therapeutic clinical study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The TriClip SystemThe 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 | Device | Subjects who receive TriClip procedure with TriClip System |
Primary outcome
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Meghan Griffin contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tricuspid Regurgitation, run by Abbott Medical Devices at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jacob Zbinden (+16517564272, jacob.zbinden@abbott.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Moderate or less Tricuspid Regurgitation (TR) at 30-day visit (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.