Cerebral Protection in Transcatheter Left Atrial Appendage Occlusion

Study acronym: LAAC-SBI
StatusUnknown
PhaseNot applicable
Started

Record status This record was last updated September 28, 2023 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.

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Record History

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  1. Changed Registry marked status Unknown (sponsor has not verified the record since Mar 2023); last known: Recruiting
  2. Start date: Mar 8, 2023 to May 26, 2023
    • Primary completion date: Sep 2025 to Dec 31, 2025
    • Eligibility criteria expanded, about 96 words
    • Collaborators: 2 to 3
    v4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 2022 to Mar 8, 2023
    • Study sites: 0 to 6
    v3
  4. Start date: May 2022 to Sep 2022
    • Primary completion date: May 2025 to Sep 2025
    • Study completion date: May 2026 to Sep 2026
    v2
  5. Study First Submitted
  • 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.
Silesian Centre for Heart Diseases
5 trials monitored
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Heart Disease
8,814 trials monitored
See 428 trials at risk
Stroke
3,537 trials monitored
See 161 trials at risk
Depression
3,069 trials monitored
See 170 trials at risk
and 1 more disease
The study aims to assess the effect of the use of neuroprotection in transcutaneous occlusion of the left atrial appendage in patients with atrial fibrillation on the risk of perioperative silent brain ischemia and associated cognitive impairment and depression.
Trial Details
NCT Number NCT05369195
Lead Sponsor Silesian Centre for Heart Diseases
Collaborators: Leszek Giec Upper-Silesian Medical Centre, Medical University of Silesia, Biostat Sp. z o.o.
Conditions
(from sponsor)		 Atrial Fibrillation, Silent Stroke, Cognitive Impairment, Depression
Related terms Atrial Fibrillation, Cognitive Dysfunction, Depression
Enrollment 240 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov