Clinical Study on the Effect of CPAP on AF Recurrence After Catheter Ablation in Patients with AF and OSA

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSecond Affiliated Hospital of Soochow University

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • CPAP

    Device

    For 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

224 Participants
are divided into 2 treatment groups
Group A: non-CPAP group1 intervention
Group B: CPAP group0 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
At 3, 6, 9, and 12 months after AF ablation
2

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

Time frame
At 3, 6, 9, and 12 months after AF ablation

Secondary outcomes

1

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

Time frame
At 3, 6, 9, and 12 months after AF ablation
2

AF burden after combination with antiarrhythmic drugs

AF burden after combination with antiarrhythmic drugs via 24-hour dynamic electrocardiogram examinatio

Time frame
At 3, 6, 9, and 12 months after AF ablation
3

SF-36

SF-36 with standard scores ranging from 0 to 100. The higher the score, the better the health status

Time frame
At 3 and 12 months after AF ablation
4

Euro-QoL5D Survey Scoring

Euro-QoL5D survey questionnaire is between 0 and 100, with higher scores indicating better health status

Time frame
At 3 and 12 months after AF ablation

Other outcomes

Sponsors and contacts

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