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Harmony TPV EMEA PMS

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Site details revised at 1 of 12 sitesv9
  2. Site details revised at 1 of 12 sitesv8
  3. Site details revised at 2 of 12 sitesv7
  4. Study sites revised (12)v6
  5. Study sites: 11 to 12v5
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  1. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 30, 2025 to Jul 30, 2025
    • Site details revised at 11 of 11 sites
    v4
  2. Study sites: 8 to 11
    • Start date: Jun 1, 2025 to Jun 30, 2025
    v3
  3. Start date: Apr 1, 2025 to Jun 1, 2025
    • Study sites: 7 to 8
    v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 Harmony Transcatheter Pulmonary Valve (TPV) System is indicated for use in the management of pediatric and adult congenital heart disease patients with severe pulmonary regurgitation (i.e., severe pulmonary regurgitation as determined by echocardiography and/or pulmonary regurgitant fraction ≥ 30% as determined by cardiac magnetic resonance imaging) who have a native or surgically-repaired right ventricular outflow tract and are clinically indicated for pulmonary valve replacement as judged by the medical team.
Trial Details
NCT Number NCT06906926
Lead Sponsor Medtronic Cardiovascular
Conditions
(from sponsor)		 Severe Pulmonary Valve Regurgitation
Related terms Pulmonary Valve Insufficiency
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov