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Start CPAP Therapy in Obstructive Sleep Apnea Patients After Atrial Fibrillation Ablation

RecruitingNAAges 18 Years - 75 YearsAllBeijing Anzhen Hospital
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In plain words

What the trial is, and whether it could suit you

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 f

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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/mยฒ and awake PaCOโ‚‚ \> 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.
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What it tests

  • Continuous Positive Airway Pressure (CPAP)
  • Usual Care
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Where

30 sites
Beijing Chaoyang Hospital, Capital Medical University
Beijing, China
Beijing Anzhen Hospital
Beijing, China
Beijing Jishuitan Hospital
Beijing, China
Beijing Hospital
Beijing, China
Peking University International Hospital
Beijing, China
Fujian Medical University Union Hospital
Fuzhou, China
First Affiliated Hospital of Fujian Medical University
Fuzhou, China
Zhangzhou Hospital of Fujian Province
Zhangzhou, China

โ€ฆand 22 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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