Start CPAP Therapy in Obstructive Sleep Apnea Patients After Atrial Fibrillation Ablation (NCT07444372) | Clinical Trial Compass
RecruitingNot Applicable
Start CPAP Therapy in Obstructive Sleep Apnea Patients After Atrial Fibrillation Ablation
China658 participantsStarted 2026-05-12
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
* Treat…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of freedom from atrial arrhythmia recurrence.