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Recruiting
NCT07586995
A Post-Market Assessment of the Safety and Performance of the TriClip™ System
Conditions: Tricuspid Regurgitation (TR)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 1000
Sponsor: Abbott Medical Devices
Location: Scripps Health La Jolla California
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 Criteria
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.
Source: ClinicalTrials.gov (NCT07586995). StuddyBuddy aggregates publicly available trial information.
