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Lifetech CeraFlex™ ASD Closure System Post-Market Clinical Follow-Up

StatusActive, Not Recruiting
PhaseNot specified
Started
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Record History

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  1. Enrollment closed, study ongoing
    • Trial sites expanded: 5 → 10 locations
    • Primary completion date changed from estimate of Dec 30, 2026 to Oct 6, 2026
    • Eligibility criteria expanded, about 2 words
  2. Study sites: 7 to 5
    • Primary completion date: Dec 2027 to Dec 30, 2026
    • Study completion date: Dec 2027 to Jun 30, 2027
    • Study description shortened, about 19 words
    v10
  3. Primary and study completion dates: Dec 2024 to Dec 2027v9
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 8 to 7
    • Start date changed from estimate of May 2024 to Jul 9, 2024
    v8
  5. Start date: Dec 2023 to May 2024
    • Primary completion date: Jun 2024 to Dec 2024
    • Study sites revised (8)
    v7
Show 5 earlier versionsHide 5 earlier versions
  1. 2 versions Re-verified since Nov 2, 2023, no change to tracked fieldsv5-v6
  2. Study sites: 9 to 8v4
  3. Study sites: 8 to 9v3
  4. Study sites: 10 to 8v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 objective of this post-market registry is to assess the clinical use of the Lifetech CeraFlex™ Closure System in a real-world and on-label fashion.
Trial Details
NCT Number NCT05887700
Lead Sponsor Lifetech Scientific (Shenzhen) Co., Ltd.
Conditions
(from sponsor)		 Atrial Septal Defect
Related terms Heart Septal Defects, Atrial
Enrollment 145 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov