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

Study acronym: TREAT TR
StatusRecruiting
PhaseNot specified
Started

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Record History

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  1. Trial sites expanded: 6 → 9 locations
    • Eligibility criteria expanded, about 7 words
  2. Study sites: 5 to 6v4
  3. Study sites: 4 to 5
    • Start date changed from estimate of Jun 2026 to Jul 2, 2026
    v3
  4. Primary endpoint(s) modified
    • Trial status changed: Enrolling by Invitation → Recruiting
    • Study sites: 3 to 4
    v2
  5. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07586995
Lead Sponsor Abbott Medical Devices
Conditions
(from sponsor)		 Tricuspid Regurgitation (TR)
Related terms Tricuspid Valve Insufficiency
Enrollment 1,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov