Clinical Trials in the USA / NCT07586995
Recruiting
Observational
A Post-Market Assessment of the Safety and Performance of the TriClip™ System
NCT07586995 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Tricuspid Regurgitation (TR)
Investigational drug(s) / intervention(s)
Tricuspid Transcatheter Edge-to-Edge Repair (TEER)
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
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.
Trial sites (9)
| Facility | City | Region | Status |
|---|---|---|---|
| Banner University Medical Center Phoenix | Phoenix | Arizona | Recruiting |
| Scripps Health | La Jolla | California | Recruiting |
| Northwestern Memorial Hospital | Chicago | Illinois | Recruiting |
| Ascension Texas Cardiovascular Research | Austin | Texas | Recruiting |
| Sentara Norfolk General Hospital | Norfolk | Virginia | Recruiting |
| St. Johannes Hospital | Dortmund | N. Rhine | Recruiting |
| Ospedale San Raffaele - Cardiac | Milan | Lombard | Recruiting |
| Hospital Universitario Central de Asturias | Oviedo | Principality of Asturias | Recruiting |
| Hospital Clínic de Barcelona | Barcelona | Spain | Recruiting |
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Official registry record
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.
View NCT07586995 on ClinicalTrials.gov ↗ ← All trials in the USA