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 post-operation. * Complete follow-up checkups either at the clinic or over the phone at 1, 3, 6, and 12 months after their procedure.
Atrial fibrillation (AF) is a common sustained cardiac arrhythmia, with recurrence rates of 20-45% after catheter ablation. Obstructive sleep apnea (OSA) is a common comorbidity and an important modifiable risk factor for post-ablation AF recurrence. Continuous positive airway pressure (CPAP) is the standard therapy for OSA, but its effect on reducing AF recurrence after ablation remains uncertain.This study evaluates whether CPAP therapy, compared with usual care, reduces atrial arrhythmia recurrence within 12 months after first-time catheter ablation in patients with AF and comorbid OSA. This prospective, multicenter, open-label, parallel-group randomized controlled trial will be conducted at approximately 20 centers in mainland China. Approximately 658 adults aged 18-75 years with persistent AF and diagnosed OSA who have successfully undergone first-time catheter ablation will be enrolled. After confirmation of eligibility and informed consent, participants will be randomized in a 1:1 ratio to receive either CPAP therapy plus usual care or usual care alone. CPAP therapy will be provided for 12 months, with treatment parameters determined by pressure titration, and adherence monitored using device-recorded data. Participants in the usual care group will receive standard AF management and standardized education regarding OSA; additional OSA treatments outside the study protocol will be permitted and documented.All participants will receive guideline-directed medical therapy for AF. Follow-up will last at least 12 months, with assessments at approximately 1, 3, 6, and 12 months after randomization. Atrial arrhythmia monitoring will be performed primarily using ambulatory ECG recorders. The primary outcome is freedom from atrial arrhythmia recurrence within 12 months after catheter ablation. Secondary outcomes include atrial arrhythmia recurrence patterns, arrhythmia-related interventions, atrial fibrillation burden, and changes in quality-of-life and psychological assessment scores.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
658
Participants receive CPAP therapy provided by the research team. Treatment parameters are determined following auto-titrating or manual pressure titration. Prior to treatment initiation, participants receive training on device usage, mask fitting and adjustment, equipment cleaning and maintenance, and data transmission methods. Study physicians and technicians provide support to address any CPAP-related discomfort. 'Good adherence' is defined as device usage of ≥ 4 hours per night on ≥ 70% of days.
Participants receive standardized medical therapy for atrial fibrillation in accordance with international guidelines and clinical routine. For OSA management, researchers provide standardized health education. This includes informing participants about the risks associated with OSA and advising on lifestyle modifications, including weight loss, adopting a lateral sleeping position, and avoiding alcohol and sedatives.
Beijing Anzhen Hospital
Beijing, Beijing Municipality, China
Beijing Jishuitan Hospital
Beijing, Beijing Municipality, China
Beijing Hospital
Beijing, Beijing Municipality, China
Peking University International Hospital
Beijing, Beijing Municipality, China
First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Langfang People's Hospital
Langfang, Hebei, China
Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Wuhan No. 1 Hospital
Wuhan, Hubei, China
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
...and 3 more locations
Incidence of freedom from atrial arrhythmia recurrence.
Recurrence is defined as a composite of: 1. Any documented atrial arrhythmia (AF / Atrial Tachycardia \[AT\] / Atrial Flutter \[AFL\]) lasting 30 seconds after a 3-month blanking period; 2. Use of Class I or III AADs after the 3-month blanking period; 3. Cardioversion performed after the 3-month blanking period; 4. Repeat catheter ablation performed at any time.
Time frame: Within 12 months
Incidence of any documented atrial arrhythmia (AF/AFL/AT) lasting ≥30 seconds.
Time frame: Within 12 months (after a 3-month blanking period).
Incidence of documented AF lasting ≥30 seconds.
Time frame: Within 12 months (after a 3-month blanking period).
Incidence of documented AT lasting ≥30 seconds.
Time frame: Within 12 months (after a 3-month blanking period).
Incidence of documented AFL lasting ≥30 seconds.
Time frame: Within 12 months (after a 3-month blanking period).
Proportion of patients using Class I or III antiarrhythmic drugs.
Time frame: Within 12 months (after a 3-month blanking period).
Proportion of patients undergoing cardioversion.
Time frame: Within 12 months (after a 3-month blanking period).
Proportion of patients undergoing repeat catheter ablation.
Time frame: Within 12 months.
AF burden
Time frame: Within 12 months.
Change in quality of life assessed by the Atrial Fibrillation Effect on Quality-of-Life questionnaire.
Scores range from 0 to 100, where higher scores indicate a better quality of life.
Time frame: Baseline, Month 12.
Change in anxiety and depression assessed by the Hospital Anxiety and Depression Scale.
Scores for both the anxiety and depression subscales range from 0 to 21, where higher scores indicate worse anxiety and depression.
Time frame: Baseline, Month 12.
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