Abbott Medical Devices
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.
TREAT TR is a prospective, observational, single-arm, multi-center, post-market study designed to confirm the safety and performance of the TriClip System in a contemporary, real-world setting in accordance with its approved indications for use. The study will be conducted at up to 100 centers globally. Clinical investigation assessments will be conducted prior to the procedure to assess eligibility. Follow-up visits after the TriClip procedure will occur at discharge, 30 days, 6 months (telephone), 12 months, and annually through 5-years. An independent echocardiographic core laboratory (ECL)…
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 o…
TriClip System
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