Clinical Trial

Evaluating Edge-to-edge Transcatheter Tricuspid Valve Repair in Patients With Severe Symptomatic Tricuspid Regurgitation

Study acronym: TRACE-NL
Enrolling by Invitation
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Summary
This is a national multicenter, open-label, randomized controlled trial to show superiority of edge-to-edge Transcatheter Tricuspid Valve repair (TTVr) on top of the Standard Of Care (SOC; heart failure medication) over the SOC alone in patients with symptomatic severe Tricuspid Regurgitation (TR) in the Netherlands.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2022-11-16; most recent amendment 2024-02-15.
Status change: Recruiting → Enrolling by Invitation 2024-02-15
Trial Details
NCT Number NCT05628779
Lead Sponsor St. Antonius Hospital
Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development
Conditions Tricuspid Valve Regurgitation, Nonrheumatic, Cardiac Catheterization, Heart Failure, Right Sided, Valve Regurgitation, Tricuspid
Enrollment 150 participants
Start Date 2022-12-12
Primary Completion 2027-11-01 (estimated)
Study Completion 2027-11-01 (estimated)
Updated on ClinicalTrials.gov 2024-02-16