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Early Feasibility Study (EFS) Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 11 months later Dec 2025 → Dec 2027
See other at-risk trials from Laplace Interventional, Inc

Record History

See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 14 words
  2. Primary completion pushed from Dec 2025 to Dec 2027v5 Show 4 more changesShow less
    • Enrollment increased: 45 → 65 participants
    • Trial sites expanded: 6 → 10 locations
    • Study completion pushed from Dec 2030 to Dec 2032
    • Eligibility criteria expanded, about 17 words
  3. Enrollment target: 10 to 45
    • Primary completion date: Mar 2025 to Dec 2025
    • Study completion date: Jun 2030 to Dec 2030
    • Site contacts updated at 1 of 6 sites
    v4
  4. Study sites: 1 to 6v3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Mar 2024 to Feb 19, 2024
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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 study is to assess the safety and technical feasibility of the Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System
Trial Details
NCT Number NCT06183684
Lead Sponsor Laplace Interventional, Inc
Conditions
(from sponsor)		 Tricuspid Regurgitation
Related terms Tricuspid Valve Insufficiency
Enrollment 65 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov