Tricuspid RegurgitationTRICARENCT06920745
TriClip CED RWE Study
An observational study of Tricuspid Regurgitation, run by Abbott Medical Devices at 1 site in United States.
Trial summary
This Coverage with Evidence Development (CED) study evaluates the long-term health outcomes of patients with symptomatic, severe or greater Tricuspid Regurgitation who received a Tricuspid Transcatheter Edge-to-Edge Repair (T-TEER) procedure using the TriClip system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tricuspid Regurgitation
- What is being tested?
- The TriClip System
- Type of treatment
- Medical device
- How many people
- 2,200 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jul 2025to Jul 2032
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Real-world patients with symptomatic, severe or greater tricuspid regurgitation in the United States
Who may be able to join
- Patients ≥ 18 years of age at time of implant
- Patients with symptomatic, severe or greater Tricuspid Regurgitation who have received the TriClip system (treatment group) or have not undergone T-TEER (control group)
Who cannot join
- Patients with less than severe Tricuspid Regurgitation
- Patients with a prior history of surgical or transcatheter tricuspid valve replacement
- Patients with a surgical or transcatheter aortic or mitral valve intervention within 90 days prior to index
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Abbott
Santa Clara, California, 95054
TRICARE, (408) 845-3000, TRICARE@abbott.com
About this study
Official title: TRIClip CoverAge With Evidence Development (CED) Real-World Evidence (RWE) Study (TRICARE)
This Coverage with Evidence Development (CED) study evaluates the long-term health outcomes of patients with symptomatic, severe or greater Tricuspid Regurgitation who received a Tricuspid Transcatheter Edge-to-Edge Repair (T-TEER) procedure using the TriClip system.
Read the detailed description
The TRICARE will assess 2-year effectiveness in patients with symptomatic, severe or greater TR who undergo Tricuspid Transcatheter Edge-to-Edge Repair (T-TEER) with the TriClip system, as compared to a contemporaneous control of patients without T-TEER.
- Conditions
- Tricuspid Regurgitation
- Being tested
- The TriClip System
- Keywords
- TriClip, Coverage with Evidence Development, Tricuspid Transcatheter Edge-to-Edge Repair
- 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
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Patients with symptomatic, severe or greater TR who received a T-TEER with the TriClip system Receives: Device: The TriClip System | |
| Control Group | Patients with symptomatic, severe or greater TR without T-TEER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of heart failure hospitalization or all-cause mortality
Compare the rate of composite endpoint at 2 years between the treatment and control groups.
Measured: 2 years
Secondary outcomes (1)
Tricuspid valve re-intervention
Report the rate at 2 years for the treatment group
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start8 Jul 2025
- Primary completionJul 2032 (estimated)
- Study completionJul 2032 (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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,200 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
- NCT06920745
- Sponsor's protocol ID
- CL1028170
- Acronym
- TRICARE
- Status last verified
- Aug 2025
- First submitted
- 3 Apr 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRIClip CoverAge With Evidence Development (CED) Real-World Evidence (RWE) Study (TRICARE)
- ClinicalTrials.gov ID
- NCT06920745
- Acronym / sponsor ID
- TRICARE / CL1028170
- Conditions
- Tricuspid Regurgitation
- Keywords
- TriClip, Coverage with Evidence Development, Tricuspid Transcatheter Edge-to-Edge Repair
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,200 participants (estimated)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 8 Jul 2025 (actual)
- Primary completion
- Jul 2032 (estimated)
- Study completion
- Jul 2032 (estimated)
- First posted
- 10 Apr 2025 (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.
This Coverage with Evidence Development (CED) study evaluates the long-term health outcomes of patients with symptomatic, severe or greater Tricuspid Regurgitation who received a Tricuspid Transcatheter Edge-to-Edge Repair (T-TEER) procedure using the TriClip system.
Detailed description
The TRICARE will assess 2-year effectiveness in patients with symptomatic, severe or greater TR who undergo Tricuspid Transcatheter Edge-to-Edge Repair (T-TEER) with the TriClip system, as compared to a contemporaneous control of patients without T-TEER.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | – | Device: The TriClip SystemPatients with symptomatic, severe or greater TR who received a T-TEER with the TriClip system |
| Control Group | – | –Patients with symptomatic, severe or greater TR without T-TEER |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Real-world patients with symptomatic, severe or greater tricuspid regurgitation in the United States
Key inclusion criteria (2 listed)
- Patients ≥ 18 years of age at time of implant
- Patients with symptomatic, severe or greater Tricuspid Regurgitation who have received the TriClip system (treatment group) or have not undergone T-TEER (control group)
Key exclusion criteria (3 listed)
- Patients with less than severe Tricuspid Regurgitation
- Patients with a prior history of surgical or transcatheter tricuspid valve replacement
- Patients with a surgical or transcatheter aortic or mitral valve intervention within 90 days prior to index
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 | Device | Treatment Group |
Primary outcome
Composite of heart failure hospitalization or all-cause mortality
Time frame: 2 years
Compare the rate of composite endpoint at 2 years between the treatment and control groups.
1 secondary outcome
Tricuspid valve re-intervention
Time frame: 2 years
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 11 Aug 2025.
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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.
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 United States.
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 3 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 11 Aug 2025. 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 United States. 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 TRICARE ((408) 845-3000, TRICARE@abbott.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of heart failure hospitalization or all-cause mortality (time frame: 2 years). 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 11 Aug 2025.