NCT07444372Recruiting
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
Source: ClinicalTrials.gov · Last updated 5 Oct 2026
Brief summary (registry, in English)
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 after randomization. * Complete follow-up checkups either at the clinic or over the phone at 1, 3, 6, and 12 months after randomization.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 658 (estimated)
- First submitted
- 25 Feb 2026
- Start date
- 12 May 2026
- Primary completion date
- 31 Jan 2029
- Lead sponsor
- Beijing Anzhen Hospital
- Diseases
- Atrial fibrillation
- NCT number
- NCT07444372
What you commit to
- Study type: Interventional
- Planned participants: 658
- From 12 May 2026 to the primary completion date, 31 Jan 2029
- 30 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- 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.
- Current participation in other drug or device trials.
Other illness
- Comorbid moderate-to-severe mitral stenosis or history of prosthetic valve replacement (mechanical or bioprosthetic).
- 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.
Lab values
- Left ventricular ejection fraction \< 30%.
- 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.
Other
- 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).
- Pregnant or breastfeeding women.
- Life expectancy \< 1 year.
- Central sleep apnea.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (30)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Hospital Coordinator of this site? Confirm its status | Beijing | China | Not yet recruiting |
| Beijing Anzhen Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Beijing Chaoyang Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Not yet recruiting |
| Peking University International Hospital Coordinator of this site? Confirm its status | Beijing | China | Not yet recruiting |
| Beijing Jishuitan Hospital Coordinator of this site? Confirm its status | Beijing | China | Not yet recruiting |
| The First Hospital of Jilin University Coordinator of this site? Confirm its status | Changchun | China | Not yet recruiting |
| The Second Xiangya Hospital of Central South University Coordinator of this site? Confirm its status | Changsha | China | Not yet recruiting |
| First Affiliated Hospital of Dalian Medical University Coordinator of this site? Confirm its status | Dalian | China | Not yet recruiting |
| Shengli Oilfield Central Hospital Coordinator of this site? Confirm its status | Dongying | China | Not yet recruiting |
| Fujian Medical University Union Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Not yet recruiting |
| First Affiliated Hospital of Fujian Medical University Coordinator of this site? Confirm its status | Fuzhou | China | Not yet recruiting |
| Second Affiliated Hospital of Harbin Medical University Coordinator of this site? Confirm its status | Harbin | China | Not yet recruiting |
| Yan'an Hospital of Kunming City Coordinator of this site? Confirm its status | Kunming | China | Not yet recruiting |
| Langfang People's Hospital Coordinator of this site? Confirm its status | Langfang | China | Not yet recruiting |
| Linyi People's Hospital Coordinator of this site? Confirm its status | Linyi | China | Not yet recruiting |
| The First Affiliated Hospital of Nanjing Medical University Coordinator of this site? Confirm its status | Nanjing | China | Not yet recruiting |
| People's Hospital of Guangxi Zhuang Autonomous Region Coordinator of this site? Confirm its status | Nanning | China | Not yet recruiting |
| First Affiliated Hospital of Ningbo University Coordinator of this site? Confirm its status | Ningbo | China | Not yet recruiting |
| Shangqiu First People's Hospital Coordinator of this site? Confirm its status | Shangqiu | China | Not yet recruiting |
| Shengjing Hospital Of China Medical University Coordinator of this site? Confirm its status | Shenyang | China | Not yet recruiting |
| First Affiliated Hospital of China Medical University Coordinator of this site? Confirm its status | Shenyang | China | Not yet recruiting |
| Shijiazhuang Great Wall Hospital of Integrated Traditional Chinese and Western Medicine Coordinator of this site? Confirm its status | Shijiazhuang | China | Recruiting |
| Second hospital of Shanxi Medical University Coordinator of this site? Confirm its status | Taiyuan | China | Not yet recruiting |
| Tianjin Chest Hospital Coordinator of this site? Confirm its status | Tianjin | China | Not yet recruiting |
| Tianjin Medical University Second Hospital Coordinator of this site? Confirm its status | Tianjin | China | Not yet recruiting |
| Wuhan NO.1 Hospital Coordinator of this site? Confirm its status | Wuhan | China | Not yet recruiting |
| Wuhan Asia General Hospital Coordinator of this site? Confirm its status | Wuhan | China | Not yet recruiting |
| The Ninth Hospital of Xingtai Coordinator of this site? Confirm its status | Xingtai | China | Recruiting |
| Zhangzhou Hospital of Fujian Province Coordinator of this site? Confirm its status | Zhangzhou | China | Not yet recruiting |
| The First Affiliated Hospital of Zhengzhou University Coordinator of this site? Confirm its status | Zhengzhou | China | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.