A Post-Market Assessment of the Safety and Performance of the TriClip™ System
ConditionTricuspid Regurgitation (TR)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAbbott Medical Devices
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Tricuspid Transcatheter Edge-to-Edge Repair (TEER)
Treatment groups
No treatment groups listed
Sponsors and collaborators
Source ClinicalTrials.gov