RecruitingNot ApplicableNCT07444372

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

Start CPAP Therapy in Obstructive Sleep Apnea Patients After Atrial Fibrillation Ablation: A Multicenter, Open-label, Randomized Clinical Trial

Sponsor

Beijing Anzhen Hospital

Enrollment

658 participants

Start Date

May 12, 2026

Study Type

INTERVENTIONAL

Conditions

Sleep-disordered breathing (SDB)Obstructive Sleep Apnea Arrhythmia Atrial Fibrillation (AF)Continuous Positive Airway Pressure Sleep Disorder (Disorder)

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria7

Patients must meet all of the following conditions to be eligible for the study:
Age 18-75 years.
Patients with persistent AF scheduled for first-time catheter ablation.
Diagnosed with OSA.
Able to tolerate CPAP therapy.
Capable of understanding and complying with the study protocol.
Willing to sign the informed consent form.

Exclusion Criteria17

Patients meeting any of the following criteria will be excluded from the study:
Secondary AF.
Left atrial anteroposterior diameter 60mm (measured via parasternal long-axis view).
Left ventricular ejection fraction < 30%.
Comorbid moderate-to-severe mitral stenosis or history of prosthetic valve replacement (mechanical or bioprosthetic).
Pregnant or breastfeeding women.
History of myocardial infarction, percutaneous coronary intervention, or cardiac surgery within 3 months prior to screening.
History of stroke or transient ischemic attack within 6 months prior to screening.
Perioperative complications related to the ablation procedure occurring prior to randomization.
Inability to discontinue antiarrhythmic drugs (AADs) post-procedure due to other reasons.
Life expectancy < 1 year.
Central sleep apnea.
Conditions requiring ventilatory support, including obesity hypoventilation syndrome (defined as BMI > 30kg/m² and awake PaCO₂ > 45mmHg), amyotrophic lateral sclerosis, or chronic obstructive pulmonary disease with > 1 episode of respiratory failure or hypercapnia.
Treatment-emergent central sleep apnea during CPAP tolerance assessment that cannot be corrected prior to randomization.
Receipt of instrumental or surgical treatment for OSA within 3 months prior to screening, including CPAP, oral appliances, ENT surgery, or bariatric surgery.
Use of glucagon-like peptide-1 receptor agonists, glucose-dependent insulinotropic peptide receptor agonists, or glucagon receptor agonists for weight loss within 3 months prior to screening, or plans to initiate such medications within the next year.
Current participation in other drug or device trials.

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Interventions

DEVICEContinuous Positive Airway Pressure (CPAP)

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.

OTHERUsual Care

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.