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A Post-Market Assessment of the Safety and Performance of the TriClip™ System

A Post-Market Assessment of the Safety and Performance of the TriClip™ System (TREAT TR)

Who can join

Ages 18 and older · All sexes

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.

About the study

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.

What is being tested

• Tricuspid Transcatheter Edge-to-Edge Repair (TEER) (device)

Sponsor: Abbott Medical Devices · Participants: 1,000 · Started: Jul 2, 2026

Contact the study team

• Allison Wood · Phone: 612-518-9034
• Jennifer Studt · Phone: 314-616-2790

Official record on ClinicalTrials.gov — NCT07586995

Locations in the U.S.

Conditions

• Tricuspid Valve Insufficiency

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.