Tricuspid Transcatheter Edge-to-Edge Repair (TEER): TriClip System
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Subject is eligible to receive the TriClip System per the current approved indications for use and is intended to undergo the procedure.
2. Subject, or their legally authorized representative, has provided written informed consent prior to study procedure.
3. Subject agrees to attend follow-up assessments.
4. Subject is ≥ 18 years of age (or legal age of consent) at time of consent.
Exclusion Criteria:
1. Subject is participating in another clinical study that could impact the follow-up or results of this study.
2. Subject has an existing TriClip implant
3. Presence of other conditions or factors that, in the Investigator's opinion, could limit the subject's ability to participate in follow-up.
Primary outcome measure(s)
Rate of Peri-Procedural Adverse Events — 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 — At 30-day follow-up
Kansas City Cardiomyopathy Questionnaire Overall Summary (KCCQ-OS) score improvement of at least 10 points — 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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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