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Follow-up Study to Monitor the Efficacy and Safety of the Occlutech® mVSD Cases

Study acronym: mVSD Registry
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 4 years 9 months later Mar 3, 2026 → Jan 1, 2031
Primary endpoint reworded 2 of 2 changed
See other at-risk trials from Occlutech International AB

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Mar 3, 2026 to Jan 1, 2031v5 Show 4 more changesShow less
    • Primary endpoint(s) modified
    • Study completion pushed from Oct 1, 2029 to Jun 1, 2031
    • Study sites: 5 to 6
    • Secondary endpoints expanded, about 38 words
  2. Enrollment target: 100 to 50v4 Show 4 more changesShow less
    • Study sites: 1 to 5
    • Interventions: muscular ventricular septal defects (Device) to Occlutech muscular ventricular septal defect (mVSD) Occluder (Device)
    • Eligibility criteria expanded, about 45 words
    • Study description expanded, about 80 words
  3. Primary completion date: Mar 3, 2023 to Mar 3, 2026v3
  4. Trial status: Active, Not Recruiting to Recruiting
    • Site details revised
    v2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 Occlutech® mVSD is indicated for percutaneous occlusion of hemodynamically or clinically significant muscular ventricular septal defects. The objectives of the study are: * To confirm the efficacy of Occlutech mVSD in patients requiring transcatheter occlusion (closure) of muscular ventricular septal defects. * To confirm the safety of Occlutech mVSD in patients requiring transcatheter occlusion (closure) of muscular ventricular septal defects.
Trial Details
NCT Number NCT05329350
Lead Sponsor Occlutech International AB
Conditions
(from sponsor)		 Muscular Ventricular Septal Defect
Related terms Heart Defects, Congenital
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov