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Persistent Atrial Fibrillation (AF) (Asia Pacific) Observational Study

Persistent Atrial Fibrillation (AF) (Asia Pacific) Observational Study

Recruiting
18 years and older
All
Phase N/A
  • Simplified description (AI rewritten)
  • Technical description (Original)

The PerAF APAC trial is a prospective, single arm, non-randomized, observational, post-market clinical investigation. Approximately 100 subjects will be enrolled at up to 15 sites in South Korea, Singapore, Hong Kong, Taiwan, and India. Centers in other countries within APAC may be approached for participation in the clinical investigation as needed. Subjects will be followed for 15-months after their initial ablation procedure. The primary effectiveness and safety endpoints will be evaluated through 15-months. A core lab will independently assess AF/AFL/AT recurrence via Holter monitoring at the 6-month and 15-month follow-up visits. All serious adverse events (SAEs) will be independently adjudicated by qualified physicians not participating in the trial

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Study details
    Arrhythmia
    Arrhythmia
    Atrial Fibrillation
    Atrial Fibrillation

NCT04244396

Abbott Medical Devices

19 February 2024

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