About this trial
Atrial fibrillation (AF) is the most common sustained arrhythmia in clinical practice, significantly increasing the risks of death, stroke, heart failure, cognitive impairment, and dementia, thus severely impacting patients' quality of life. However, for AF patients with concomitant cardiovascular risk factors, particularly those with obstructive sleep apnea (OSA), the success rate of catheter ablation is significantly reduced. Continuous positive airway pressure (CPAP) is currently an effective treatment for OSA, effectively correcting nocturnal intermittent hypoxia and fragmented sleep caused by OSA. However, the effect of CPAP therapy on AF recurrence in patients with OSA undergoing catheter ablation remains controversial. Faced with conflicting research findings, our team recently conducted a meta-analysis (registration number CRD42023398588) to assess the impact of CPAP on AF recurrence post catheter ablation in patients with AF and OSA, suggesting that CPAP significantly reduces AF recurrence post catheter ablation (RR = 0.58, P \< 0.01). However, considering the limited number of included studies, potential bias risks, and confounding factors, our meta-analysis results await further confirmation through real-world studies by our team. Therefore, our team plans to conduct further research on the impact of CPAP on AF recurrence post catheter ablation in patients with moderate to severe OSA, aiming to provide clinical guidance for the treatment of AF in patients with moderate to severe OSA.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Clinical diagnosis of AF combined with moderate to severe OSA (OSA diagnostic criteria: apnea hypopnea index (AHI) greater than 15/hour, and at least 80% of all events are respiratory sleep obstructive events; AF includes persistent atrial fibrillation and paroxysmal atrial fibrillation)
Age ≥ 18 years old
The patient voluntarily participates in the project and signs informed consent
All patients undergo overnight sleep pressure titration at the sleep center to determine the minimum pressure value for continuous positive airway pressure ventilation at home. All patients are required to undergo CPAP treatment at home at least 5 days a week, with each session lasting at least 4 hours
Disqualifiers
Patients with neuromuscular disorders, pulmonary hypopnea, and severe lung diseases
Preoperative confirmation of thrombus in the left atrium
The patient has no desire for conversion
Secondary atrial fibrillation (hyperthyroidism, tumors, etc.)
Trial population
Clinical diagnosis of AF combined with moderate to severe OSA (OSA diagnostic criteria: apnea hypopnea index (AHI) greater than 15/hour, and at least 80% of all events are respiratory sleep obstructive events; AF includes persistent atrial fibrillation and paroxysmal atrial fibrillation)
Trial design
Cohort
Prospective
Treatments tested in this trial
CPAP
DeviceFor the non-CPAP group, the intervention includes catheter ablation and conventional treatment for AF combined with OSA; For the CPAP group, the intervention includes catheter ablation and CPAP treatment for AF combined with OSA
Treatment groups
Trial outcomes
Primary outcomes
AF recurrence after ablation
AF recurrence after ablation via Surface electrocardiogram and 24-hour dynamic electrocardiogram examination. If there are symptoms, seek medical attention at any time for electrocardiogram examination
AF burden after ablation AF burden after ablation AF burden after ablation
AF burden after ablation via 24-hour dynamic electrocardiogram examination AF burden after ablation via 24-hour dynamic electrocardiogram examinatio AF burden after ablation via 24-hour dynamic electrocardiogram examinatio
Secondary outcomes
The recurrence of AF after combination with antiarrhythmic drugs
The recurrence of AF after combination with antiarrhythmic drugs via Surface electrocardiogram and 24-hour dynamic electrocardiogram examination. If there are symptoms, seek medical attention at any time for electrocardiogram examination
AF burden after combination with antiarrhythmic drugs
AF burden after combination with antiarrhythmic drugs via 24-hour dynamic electrocardiogram examinatio
SF-36
SF-36 with standard scores ranging from 0 to 100. The higher the score, the better the health status
Euro-QoL5D Survey Scoring
Euro-QoL5D survey questionnaire is between 0 and 100, with higher scores indicating better health status
Sponsors and contacts
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