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Safety and Effectiveness of Short-Term Single AntiPlatelet Therapy After Left Atrial Appendage Closure With the LAmbre Device in Patients With Nonvalvular Atrial Fibrillation: A Multinational Real-world Registry

Study acronym: S-SAPT LAMBRE
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated July 4, 2025 (before its estimated October 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Study sites: 21 to 22v18
  2. Study sites: 20 to 21v17
  3. Study sites: 19 to 20v16
  4. Study sites: 18 to 19v15
  5. Study sites: 17 to 18v14
Show 12 earlier versionsHide 12 earlier versions
  1. Study sites: 14 to 17v13
  2. Study sites: 13 to 14v12
  3. Study sites: 10 to 13v11
  4. Study sites: 9 to 10v10
  5. Study sites: 8 to 9v9
  6. Study sites: 7 to 8v8
  7. Study sites: 6 to 7v7
  8. Study sites: 5 to 6v6
  9. Study sites: 4 to 5v5
  10. Study sites: 3 to 4v4
  11. Study sites: 1 to 3v3
  12. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Primary completion date: Oct 2026 to Oct 1, 2026 · Completion date: Oct 2027 to Oct 1, 2027 · 2 morev2 Show 5 more changesShow less
    • Study sites: 0 to 1
    • Primary completion date: Oct 2026 to Oct 1, 2026
    • Completion date: Oct 2027 to Oct 1, 2027
    • Start date: Oct 1, 2024 to Oct 10, 2024
    • Eligibility criteria expanded, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Brief Summary: A prospective, multicenter, single-arm, non-randomized study including consecutive patients with nonvalvular AF(Atrial Fibrillation), with a CHA2DS2-VASc score ≥2 (men) or ≥3 (women), and contraindication for long-term anticoagulant treatment, with successful LAAC (Left Atrial Appendage Closure)procedure with the LAmbre device, who at discharge are eligible for short-term (3-months-only) SAPT. We want to assess if a short-term single antiplatelet therapeutic regime of Acetylsalicylic acid (ASA) 100 mg (or clopidogrel 75 mg if ASA contraindication), once daily, for 3 months is safe and effective at 12 months follow-up.
Trial Details
NCT Number NCT06620757
Lead Sponsor Fundación EPIC
Conditions Atrial Fibrillation
Enrollment 234 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov