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An International Multicenter Study on Transcatheter Device Closure of Perimembranous Ventricular Septal Defects

Study acronym: PERI-CLOSE
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 5 months later Jul 31, 2026 → Dec 31, 2026
Primary endpoints removed 6 → 1 primary endpoints
See other at-risk trials from Fondation Hôpital Saint-Joseph

Record History

See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fieldsv4
  2. Enrollment increased: 1500 → 2000 participants
    • Eligibility criteria shortened, about 186 words
    v3
  3. Primary endpoint(s) modifiedv2 Show 8 more changesShow less
    • Recruitment opened
    • Enrollment increased: 1000 → 1500 participants
    • Primary completion pushed from Jul 31, 2026 to Dec 31, 2026
    • Trial sites expanded: 18 → 25 locations
    • Study completion pushed from Jul 31, 2026 to Jun 30, 2027
    • Start date changed from estimate of Mar 1, 2025 to Jan 1, 2025
    • Eligibility criteria revised
    • Secondary endpoints: 4 to 6
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 international multicenter registry aims to gather real-world data on patient outcomes and assess the procedural success and performance of various device occluders used in the transcatheter treatment of pediatric and adult patients with perimembranous ventricular septal defects (PmVSD).
Trial Details
NCT Number NCT06823635
Lead Sponsor Fondation Hôpital Saint-Joseph
Conditions
(from sponsor)		 Perimembranous Ventricular Septal Defect
Related terms Cardiovascular Abnormalities, Heart Defects, Congenital, Heart Septal Defects, Heart Septal Defects, Ventricular
Enrollment 2,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov