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Start CPAP Therapy in Obstructive Sleep Apnea Patients After Atrial Fibrillation Ablation

Study acronym: STOP-AFib
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Trial sites expanded: 27 → 30 locations Show 4 more changesShow less
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints: details revised at 1 of 10 entries
    • Study description expanded, about 8 words
    • Publications: details revised at 10 of 10 entries
  2. Notable Recruitment opened
    • Trial sites expanded: 13 → 27 locations
    • Start date changed from estimate of May 1, 2026 to May 12, 2026
    v3
  3. Minor Start date: Apr 15, 2026 to May 1, 2026
    • Secondary endpoints: details revised at 2 of 10 entries
    v2
  4. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 (AF) is one of the most common clinical arrhythmias. Catheter ablation is an effective therapeutic strategy; however, recurrence rates remain substantial, ranging from 20% to 45%. Previous studies have established a strong association between obstructive sleep apnea (OSA) and the risk of AF recurrence following ablation. While continuous positive airway pressure (CPAP) is the standard intervention for OSA, and some observational studies suggest it may reduce post-ablation recurrence in patients with comorbid OSA, small randomized controlled trials have failed to confirm a clear benefit, potentially due to poor adherence. This study aims to evaluate the clinical benefit of post-ablation CPAP therapy in AF patients with comorbid OSA. Participants will: * Be randomly assigned to either the CPAP group or the usual care group. * If in the CPAP group, use a CPAP device for 12 months. * Wear an ambulatory ECG recorder for a 7-day period at 3, 6, 9, and 12 months after randomization. * Complete follow-up checkups either at the clinic or over the phone at 1, 3, 6, and 12 months after randomization.
Trial Details
NCT Number NCT07444372
Lead Sponsor Beijing Anzhen Hospital
Conditions
(from sponsor)
Obstructive Sleep Apnea, Sleep Disorder (Disorder), Atrial Fibrillation (AF), Sleep Disordered Breathing (SDB), Arrhythmia, Continuous Positive Airway Pressure
Related terms Arrhythmias, Cardiac, Atrial Fibrillation, Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Sleep Wake Disorders
Enrollment 658 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov