A Post-Market Assessment of the Safety and Performance of the TriClip™ System
Recruiting now
Conditions studied: Tricuspid Regurgitation (TR)
In brief
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.
Key facts
- Study ID
- NCT07586995
- Run by
- Abbott Medical Devices
- People needed
- 1000
- Starts
- 2026-07-02
- Expected to finish
- 2033-08-01
- Last updated by the study team
- 2026-08-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Ascension Texas Cardiovascular Research — Austin, Texas, United States (enrolling)
- Hospital Clínic de Barcelona — Barcelona, Spain (enrolling)
- Scripps Health — La Jolla, California, United States
- Northwestern Memorial Hospital — Chicago, Illinois, United States
- Ospedale San Raffaele - Cardiac — Milan, Lombard, Italy
Full record on ClinicalTrials.gov
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