NCT07444372 Start CPAP Therapy in Obstructive Sleep Apnea Patients After Atrial Fibrillation Ablation
| NCT ID | NCT07444372 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beijing Anzhen Hospital |
| Condition | Obstructive Sleep Apnea |
| Study Type | INTERVENTIONAL |
| Enrollment | 658 participants |
| Start Date | 2026-05-12 |
| Primary Completion | 2029-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 658 participants in total. It began in 2026-05-12 with a primary completion date of 2029-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07444372 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Obstructive Sleep Apnea. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07444372 currently recruiting?
Yes, NCT07444372 is actively recruiting participants. Contact the research team at frank782008@aliyun.com for enrollment information.
Where is the NCT07444372 trial being conducted?
This trial is being conducted at Beijing, China, Beijing, China, Beijing, China, Beijing, China and 11 additional locations.
Who is sponsoring the NCT07444372 clinical trial?
NCT07444372 is sponsored by Beijing Anzhen Hospital. The trial plans to enroll 658 participants.