Tricuspid Regurgitation (TR)TREAT TRNCT07586995
A Post-Market Assessment of the Safety and Performance of the TriClip™ System
An observational study of Tricuspid Regurgitation (TR), run by Abbott Medical Devices at 14 sites in 5 countries.
Trial summary
The objective of the TREAT TR study is to confirm the safety and performance of the TriClip System for tricuspid TEER in a contemporary, real-world setting, using the commercially available device in accordance with its approved indications for use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tricuspid Regurgitation (TR)
- What is being tested?
- Tricuspid Transcatheter Edge-to-Edge Repair (TEER)
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 14 sitesin 5 countries
- Study dates
- 2 Jul 2026to Aug 2033
- 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: This clinical investigation will enroll subjects from the general population who are scheduled to undergo the TriClip procedure per the current approved regional IFU.
Who may be able to join
- Subject is eligible to receive the TriClip System per the current approved indications for use and is intended to undergo the procedure.
- Subject, or their legally authorized representative, has provided written informed consent prior to study procedure.
- Subject agrees to attend follow-up assessments.
- Subject is ≥ 18 years of age (or legal age of consent) at time of consent.
Who cannot join
- Subject is participating in another clinical study that could impact the follow-up or results of this study.
- Subject has an existing TriClip implant
- Presence of other conditions or factors that, in the Investigator's opinion, could limit the subject's ability to participate in follow-up.
Trial locations and contacts
14 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
14 sites in 5 countries
United States8 sites, 8 recruiting
- Recruiting
Ascension Texas Cardiovascular Research
Austin, Texas, 78705
Pallavi Noojibail, 512-324-3434, Pallavi.Noojibail@ascension.org
Mark Gajjar, MD
- Recruiting
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Maggie McNamara, 312-926-0846, margaret.mcnamara@nm.org
Akhil Narang, MD
- Recruiting
Ascension Alexian Brothers
Elk Grove, Illinois, 60007
Jeanine Pilat, 847-981-2045, jeanine.pilat@ascension.org
Andrei Pop, MD
- Recruiting
UTHealth Memorial Hermann
Houston, Texas, 77030
Angela Scott, 713-486-6739, Angela.Scott@uth.tmc.edu
Biswajit Kar, MD
- Recruiting
Scripps Health
La Jolla, California, 92037
John Gil-Flamer, 858-824-5238, Gil-Flamer.John@scrippshealth.org
Matthew Price, MD
- Recruiting
Mount Sinai Hospital
New York, New York, 10029
Sowmya Chittari, sowmyasri.chittari@mountsinai.org
Annapoorna Kini, MD
- Recruiting
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
Patricia Rombaoa, 757-388-1568, prromba1@sentara.com
Joshua Cohen, MD
- Recruiting
Banner University Medical Center Phoenix
Phoenix, Arizona, 85006
Sydney Mintalar, Sydney.Mintalar@bannerhealth.com
Paul Sorajja, MD
Germany2 sites, 2 recruiting
- Recruiting
St. Johannes Hospital
Dortmund, N. Rhine, 44137
Bettina Lippold, +49 23147644730, lippold@cardiacresearch.de
Helge Moellmann, Professor Dr. med
- Recruiting
Robert-Bosch-Krankenhaus
Stuttgart, 70376
Renate Ingensiep, Renate.Ingensiep@bosch-health-campus.com
Philipp Nikolai, Dr. med.
Spain2 sites, 2 recruiting
- Recruiting
Hospital Clínic de Barcelona
Barcelona, 08036
Anna Campos, +34 934518746, acampos@clinic.cat
Xavier Freixa Rofastes
- Recruiting
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33011
Esther Villa, fundacionasturcor@gmail.com
Pablo Avanzas, MD, PhD
France1 site, 1 recruiting
- Recruiting
CHU Rennes, Pontchaillou
Rennes, 35033
Emmanuelle Babin-Lerede, emmanuelle.babin.lerede@chu-rennes.fr
Guillaume Leurent, Dr. med.
Italy1 site, 1 recruiting
- Recruiting
Ospedale San Raffaele - Cardiac
Milan, Lombard, 20132
Davide Schiavi, +39 3335206687, schiavi.davide@hsr.it
Francesco Maisano, Prof.
About this study
Official title: A Post-Market Assessment of the Safety and Performance of the TriClip™ System (TREAT TR)
The objective of the TREAT TR study is to confirm the safety and performance of the TriClip System for tricuspid TEER in a contemporary, real-world setting, using the commercially available device in accordance with its approved indications for use.
Read the detailed description
TREAT TR is a prospective, observational, single-arm, multi-center, post-market study designed to confirm the safety and performance of the TriClip System in a contemporary, real-world setting in accordance with its approved indications for use. The study will be conducted at up to 100 centers globally. Clinical investigation assessments will be conducted prior to the procedure to assess eligibility. Follow-up visits after the TriClip procedure will occur at discharge, 30 days, 6 months (telephone), 12 months, and annually through 5-years. An independent echocardiographic core laboratory (ECL) will be utilized for evaluating echocardiograms. An imaging substudy will be conducted at a subset of participating sites in up to 250 subjects who consent to participate in the substudy. Cardiac-gated computed tomography (CT) will be performed at baseline and 12 months to evaluate reverse cardiac remodeling.
- Conditions
- Tricuspid Regurgitation (TR)
- Being tested
- Tricuspid Transcatheter Edge-to-Edge Repair (TEER)
- Keywords
- Tricuspid Regurgitation, Tricuspid, Cardiovascular, Tricuspid Valve Insufficiency, ABT-CIP-10594, Tricuspid Regurgitation (TR), Transcatheter Edge-To-Edge Repair (TEER)
- 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.
Tricuspid Transcatheter Edge-to-Edge Repair (TEER)Device
TriClip System
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Peri-Procedural Adverse Events
Defined as all-cause mortality, device embolization, device thrombosis, non-elective surgery or transcatheter intervention for device- or procedure-related adverse event (AE) new pacemaker implantation and device- or procedure related major bleeding
Measured: Through 30 days post-procedure
Tricuspid Regurgitation (TR) grade less than or equal to moderate
Measured: At 30-day follow-up
Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS) score improvement of at least 10 points
All KCCQ scores are scaled from 0 (worst) to 100 (best possible status), where the higher score reflects a better health status.
Measured: At 30-day follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start2 Jul 2026
- Primary completionSep 2028 (estimated)
- Study completionAug 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tricuspid Regurgitation (TR)Studies 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Meghan Griffin, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07586995
- Sponsor's protocol ID
- ABT-CIP-10594
- Acronym
- TREAT TR
- Status last verified
- Jul 2026
- First submitted
- 8 May 2026
- Last updated
- 6 Nov 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 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-Market Assessment of the Safety and Performance of the TriClip™ System (TREAT TR)
- ClinicalTrials.gov ID
- NCT07586995
- Acronym / sponsor ID
- TREAT TR / ABT-CIP-10594
- Conditions
- Tricuspid Regurgitation (TR)
- Keywords
- Tricuspid Regurgitation, Tricuspid, Cardiovascular, Tricuspid Valve Insufficiency, ABT-CIP-10594, Tricuspid Regurgitation (TR), Transcatheter Edge-To-Edge Repair (TEER)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 2 Jul 2026 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Aug 2033 (estimated)
- First posted
- 14 May 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 objective of the TREAT TR study is to confirm the safety and performance of the TriClip System for tricuspid TEER in a contemporary, real-world setting, using the commercially available device in accordance with its approved indications for use.
Detailed description
TREAT TR is a prospective, observational, single-arm, multi-center, post-market study designed to confirm the safety and performance of the TriClip System in a contemporary, real-world setting in accordance with its approved indications for use. The study will be conducted at up to 100 centers globally. Clinical investigation assessments will be conducted prior to the procedure to assess eligibility. Follow-up visits after the TriClip procedure will occur at discharge, 30 days, 6 months (telephone), 12 months, and annually through 5-years. An independent echocardiographic core laboratory (ECL) will be utilized for evaluating echocardiograms. An imaging substudy will be conducted at a subset of participating sites in up to 250 subjects who consent to participate in the substudy. Cardiac-gated computed tomography (CT) will be performed at baseline and 12 months to evaluate reverse cardiac remodeling.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This clinical investigation will enroll subjects from the general population who are scheduled to undergo the TriClip procedure per the current approved regional IFU.
Key inclusion criteria (4 listed)
- Subject is eligible to receive the TriClip System per the current approved indications for use and is intended to undergo the procedure.
- Subject, or their legally authorized representative, has provided written informed consent prior to study procedure.
- Subject agrees to attend follow-up assessments.
- Subject is ≥ 18 years of age (or legal age of consent) at time of consent.
Key exclusion criteria (3 listed)
- Subject is participating in another clinical study that could impact the follow-up or results of this study.
- Subject has an existing TriClip implant
- Presence of other conditions or factors that, in the Investigator's opinion, could limit the subject's ability to participate in follow-up.
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 |
|---|---|---|
| Tricuspid Transcatheter Edge-to-Edge Repair (TEER)TriClip System | Device | – |
Primary outcome
Rate of Peri-Procedural Adverse Events
Time frame: Through 30 days post-procedure
Defined as all-cause mortality, device embolization, device thrombosis, non-elective surgery or transcatheter intervention for device- or procedure-related adverse event (AE) new pacemaker implantation and device- or procedure related major bleeding
Tricuspid Regurgitation (TR) grade less than or equal to moderate
Time frame: At 30-day follow-up
Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS) score improvement of at least 10 points
Time frame: At 30-day follow-up
All KCCQ scores are scaled from 0 (worst) to 100 (best possible status), where the higher score reflects a better health status.
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 6 Nov 2026.
- Individual participant dataSharing planned: No
Related trials for Tricuspid Regurgitation (TR)
Not yet recruiting
TRI-SUCCESS - Tricuspid Regurgitation Study of the Unica™ Cross-Caval System for the Evaluation of Efficacy and Safety in Significant TR Subjects
Tricuspid Regurgitation, Tricuspid Regurgitation Functional
Recruiting
Innoventric Trillium™ Stent Graft Early Feasibility Study (EFS)
Tricuspid Regurgitation, Tricuspid Regurgitation Functional
Recruiting
First-in-man Trial to Assess the Safety, Performance and Clinical Benefit of the TRICENTO G2 Transcatheter Valve System for Tricuspid Regurgitation
Symptomatic Tricuspid Regurgitation (TR) Graded as Severe or Greater
Recruiting
The TRICURE US IDE Pivotal Study
Tricuspid Regurgitation (TR)
Recruiting
EFS of the DUO System for Tricuspid Regurgitation
Tricuspid Regurgitation, Tricuspid Valve Insufficiency
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 study director
Abbott
14 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tricuspid Regurgitation (TR), run by Abbott Medical Devices at 14 sites in 5 countries.
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 4 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 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Germany, Spain, France, Italy. 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 Allison Wood (612-518-9034, allison.wood@abbott.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Peri-Procedural Adverse Events (time frame: Through 30 days post-procedure). The study lists 3 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 6 Nov 2026.