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MASA Valve Early Feasibility Study

Study acronym: MVEFS
StatusRecruiting
PhaseNot applicable
SponsorPECA Labs
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated November 6, 2024 (before its estimated April 1, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary completion date: Apr 1, 2024 to Apr 1, 2025
    • Study sites: 6 to 5
    v7
  2. Site details revised at 1 of 6 sitesv6
  3. Study sites: 4 to 6
    • Start date changed from estimate of May 25, 2023 to May 18, 2023
    v5
  4. Start date: Apr 10, 2023 to May 25, 2023
    • Study sites: 3 to 4
    v4
  5. Start date: Feb 7, 2023 to Apr 10, 2023
    • Study sites: 2 to 3
    v3
  6. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Start date: Jul 2022 to Feb 7, 2023
    • Study sites: 1 to 2
    • Primary completion date: Dec 2023 to Apr 1, 2024
    • Study completion date: Dec 2027 to Apr 1, 2028
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
PECA Labs
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The MASA Valve Early Feasibility Study (MVEFS) multi-site interventional clinical trial within the United States of America with each center following a common protocol.The objective of the trial is to evaluate the safety and probable benefit of MASA Valve in the indicated subset of patients requiring Right Ventricular Outflow Tract Reconstruction (RVOTR). As an early feasibility study, the purpose is determine the feasibility of success of the device in order to gather early data towards a future pivotal study and/or regulatory clearance submission.
Trial Details
NCT Number NCT05452720
Lead Sponsor PECA Labs
Conditions
(from sponsor)		 Tetrology of Fallot, Pulmonary Stenosis, Truncus Arteriosus, Transposition of Great Vessels, Pulmonary Atresia, Ross Procedure
Related terms Pulmonary Atresia, Pulmonary Valve Stenosis, Tetralogy of Fallot, Transposition of Great Vessels, Truncus Arteriosus, Persistent
Enrollment 10 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov