Start CPAP After AF Ablation in OSA Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, open-label randomized trial will enroll adults with persistent atrial fibrillation who have undergone first-time catheter ablation and coexisting obstructive sleep apnea. Participants are randomized to receive either continuous positive airway pressure (CPAP) therapy plus usual care for 12 months or usual care alone, with CPAP parameters determined by titration and device-recorded adherence monitored. The primary goal is to see if post-ablation CPAP increases the rate of no recurrent atrial fibrillation over a one-year period, using ambulatory ECG monitoring at 3, 6, 9, and 12 months. The study will be conducted at about 20 centers in mainland China and will collect standard AF management data and OSA education for all participants.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Patients must meet all of the following conditions to be eligible for the study:

* Age 18-75 years.
* Patients with persistent AF who received catheter ablation for the first time.
* 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 Criteria:

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.

Where it's running

• Beijing Anzhen Hospital
  Beijing, Beijing Municipality, China Recruiting
• Shijiazhuang Great Wall Hospital of Integrated Traditional Chinese and Western Medicine
  Shijiazhuang, Hebei, China Recruiting
• The Ninth Hospital of Xingtai
  Xingtai, Hebei, China Recruiting
• Beijing Chaoyang Hospital, Capital Medical University
  Beijing, Beijing Municipality, China Not yet recruiting
• Beijing Jishuitan Hospital
  Beijing, Beijing Municipality, China Not yet recruiting
• Beijing Hospital
  Beijing, Beijing Municipality, China Not yet recruiting

Study contacts

• Study coordinator: Jiang Xie, Professor
• Email: frank782008@aliyun.com
• Phone: +86 64456360

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.