Start CPAP Therapy in Obstructive Sleep Apnea Patients After Atrial Fibrillation Ablation
Recruiting · NCT07444372 · Interventional (participants receive a specific treatment) · Lead sponsor: Beijing Anzhen Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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 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 is running
27 locations listed.
- Beijing Chaoyang Hospital, Capital Medical University - Beijing, Beijing Municipality, China
- 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
- Fujian Medical University Union Hospital - Fuzhou, Fujian, China
- First Affiliated Hospital of Fujian Medical University - Fuzhou, Fujian, China
- Zhangzhou Hospital of Fujian Province - Zhangzhou, Fujian, China
- People's Hospital of Guangxi Zhuang Autonomous Region - Nanning, Guangxi, China
- Langfang People's Hospital - Langfang, Hebei, China
- Shijiazhuang Great Wall Hospital of Integrated Traditional Chinese and Western Medicine - Shijiazhuang, Hebei, China
- The Ninth Hospital of Xingtai - Xingtai, Hebei, China
- Second Affiliated Hospital of Harbin Medical University - Harbin, Heilongjiang, China
- The First Affiliated Hospital of Zhengzhou University - Zhengzhou, Henan, China
- Wuhan No. 1 Hospital - Wuhan, Hubei, China
- Wuhan Asia General Hospital - Wuhan, Hubei, China
- The Second Xiangya Hospital of Central South University - Changsha, Hunan, China
- The First Affiliated Hospital of Nanjing Medical University - Nanjing, Jiangsu, China
- The First Hospital of Jilin University - Changchun, Jilin, China
- First Affiliated Hospital of Dalian Medical University - Dalian, Liaoning, China
- First Affiliated Hospital of China Medical University - Shenyang, Liaoning, China
- Shengjing Hospital of China Medical University - Shenyang, Liaoning, China
- Shengli Oilfield Central Hospital - Dongying, Shandong, China
- Linyi People's Hospital - Linyi, Shandong, China
- Second Hospital of Shanxi Medical University - Taiyuan, Shanxi, China
- Tianjin Chest Hospital - Tianjin, Tianjin Municipality, China
- First Affiliated Hospital of Ningbo University - Ningbo, Zhejiang, China