An observational study in Tricuspid Regurgitation (TR), sponsored by Abbott Medical Devices. Recruiting at 14 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Abbott Medical Devices (part of Abbott) · Observational
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.
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.
226 studies on the registry are indexed under Tricuspid Valve Insufficiency; 109 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 200 across 94 observational studies indexed under Tricuspid Valve Insufficiency.
Browse Tricuspid Valve Insufficiency studies →Abbott Medical Devices is the lead sponsor of 539 studies on the registry; 33 are open to participants now.
Of its 53 completed or terminated interventional studies of FDA-regulated products, 44 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
This clinical investigation will enroll subjects from the general population who are scheduled to undergo the TriClip procedure per the current approved regional IFU.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TriClip System
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
Time frame: Through 30 days post-procedure
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
All KCCQ scores are scaled from 0 (worst) to 100 (best possible status), where the higher score reflects a better health status.
Time frame: At 30-day follow-up
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Tricuspid Valve Insufficiency →