A Post-Market Assessment of the Safety and Performance of the TriClip™ System
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tricuspid Transcatheter Edge-to-Edge Repair (TEER).
- Who it may be relevant to
- Registry conditions: Tricuspid Regurgitation (TR). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Italy, Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Post-Market Assessment of the Safety and Performance of the TriClip™ System (TREAT TR)
Overview
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.
Interventions
- Device Tricuspid Transcatheter Edge-to-Edge Repair (TEER)
TriClip System
Primary outcome measures
- Rate of Peri-Procedural Adverse Events [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 [Time frame: At 30-day follow-up]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 3 centers
- Scripps Health — La Jolla
- Northwestern Memorial Hospital — Chicago
- Ascension Texas Cardiovascular Research — Austin
Italy · 1 center
- Ospedale San Raffaele - Cardiac — Milan
Spain · 1 center
- Hospital Clínic de Barcelona — Barcelona
Identifiers
NCT: NCT07586995 · ABT-CIP-10594