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Comparison of LAA-Closure vs Oral Anticoagulation in Patients With NVAF and Status Post Intracranial Bleeding.

Study acronym: CLEARANCE
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Trial sites expanded: 33 → 39 locationsv6
  2. Primary completion date: Jun 2027 to Jun 2029v5 Show 4 more changesShow less
    • Study sites: 42 to 33
    • Study completion date: Jun 2027 to Dec 2029
    • Primary endpoints revised (4)
    • Collaborators expanded, about 1 word
  3. Primary and study completion dates: Jun 2025 to Jun 2027v4 Show 4 more changesShow less
    • Enrollment target: 550 to 530
    • Study sites: 28 to 42
    • Eligibility criteria shortened, about 20 words
    • Secondary endpoints: details revised at 10 of 10 entries
  4. Study sites: 1 to 28v3
  5. Trial status: Not Yet Recruiting to Recruitingv2 Show 5 more changesShow less
    • Primary endpoints revised (4)
    • Study sites: 0 to 1
    • Primary and study completion dates: Mar 2025 to Jun 2025
    • Start date changed from estimate of Mar 2020 to Jun 16, 2020
    • Eligibility criteria revised
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Atrial fibrillation is the most common cardiac arrhythmia. In atrial fibrillation, there is a risk that clots can form in the heart, especially in the left atrium. If these clots come loose, there is a risk of stroke. To prevent strokes, patients with atrial fibrillation and status post ICB can be treated with anticoagulants. This medication therapy prevents blood clots from forming in the heart, but can also cause bleeding. Another therapy option is the occlusion of the left atrium. After closure of the left atrium, only a short anticoagulation therapy is necessary until the occluder has healed. The aim of the study is to compare these two treatment approaches. In this study only already approved drugs and occlusion systems will be used.
Trial Details
NCT Number NCT04298723
Lead Sponsor Jena University Hospital
Collaborators: KCRI
Conditions
(from sponsor)		 Intracranial Hemorrhages, Atrial Fibrillation (AF), Atrial Flutter
Related terms Atrial Fibrillation, Atrial Flutter, Intracranial Hemorrhages
Enrollment 530 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov