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

Official title

Start CPAP Therapy in Obstructive Sleep Apnea Patients After Atrial Fibrillation Ablation: A Multicenter, Open-label, Randomized Clinical Trial

Overview

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.

Detailed description

Atrial fibrillation (AF) is a common sustained cardiac arrhythmia, with recurrence rates of 20-45% after catheter ablation. Obstructive sleep apnea (OSA) is a common comorbidity and an important modifiable risk factor for post-ablation AF recurrence. Continuous positive airway pressure (CPAP) is the standard therapy for OSA, but its effect on reducing AF recurrence after ablation remains uncertain.This study evaluates whether CPAP therapy, compared with usual care, reduces atrial arrhythmia recurrence within 12 months after first-time catheter ablation in patients with AF and comorbid OSA.

This prospective, multicenter, open-label, parallel-group randomized controlled trial will be conducted at approximately 20 centers in mainland China. Approximately 658 adults aged 18-75 years with persistent AF and diagnosed OSA who have successfully undergone first-time catheter ablation will be enrolled.

After confirmation of eligibility and informed consent, participants will be randomized in a 1:1 ratio to receive either CPAP therapy plus usual care or usual care alone. CPAP therapy will be provided for 12 months, with treatment parameters determined by pressure titration, and adherence monitored using device-recorded data. Participants in the usual care group will receive standard AF management and standardized education regarding OSA; additional OSA treatments outside the study protocol will be permitted and documented.All participants will receive guideline-directed medical therapy for AF.

Follow-up will last at least 12 months, with assessments at approximately 1, 3, 6, and 12 months after randomization. Atrial arrhythmia monitoring will be performed primarily using ambulatory ECG recorders.

The primary outcome is freedom from atrial arrhythmia recurrence within 12 months after catheter ablation. Secondary outcomes include atrial arrhythmia recurrence patterns, arrhythmia-related interventions, atrial fibrillation burden, and changes in quality-of-life and psychological assessment scores.

Interventions

• Device Continuous Positive Airway Pressure (CPAP)
  Participants receive CPAP therapy provided by the research team. Treatment parameters are determined following auto-titrating or manual pressure titration. Prior to treatment initiation, participants receive training on device usage, mask fitting and adjustment, equipment cleaning and maintenance, and data transmission methods. Study physicians and technicians provide support to address any CPAP-related discomfort. 'Good adherence' is defined as device usage of ≥ 4 hours per night on ≥ 70% of da
• Other Usual Care
  Participants receive standardized medical therapy for atrial fibrillation in accordance with international guidelines and clinical routine. For OSA management, researchers provide standardized health education. This includes informing participants about the risks associated with OSA and advising on lifestyle modifications, including weight loss, adopting a lateral sleeping position, and avoiding alcohol and sedatives.

Primary outcome measures

• Incidence of freedom from atrial arrhythmia recurrence. [Time frame: Within 12 months]

Secondary outcome measures (10)

• Incidence of any documented atrial arrhythmia (AF/AFL/AT) lasting ≥30 seconds. [Time frame: Within 12 months (after a 3-month blanking period).]
• Incidence of documented AF lasting ≥30 seconds. [Time frame: Within 12 months (after a 3-month blanking period).]
• Incidence of documented AT lasting ≥30 seconds. [Time frame: Within 12 months (after a 3-month blanking period).]
• Incidence of documented AFL lasting ≥30 seconds. [Time frame: Within 12 months (after a 3-month blanking period).]
• Proportion of patients using Class I or III antiarrhythmic drugs. [Time frame: Within 12 months (after a 3-month blanking period).]
• Proportion of patients undergoing cardioversion. [Time frame: Within 12 months (after a 3-month blanking period).]
• Proportion of patients undergoing repeat catheter ablation. [Time frame: Within 12 months.]
• AF burden [Time frame: Within 12 months.]
• Change in quality of life assessed by the Atrial Fibrillation Effect on Quality-of-Life questionnaire. [Time frame: Baseline, Month 12.]
• Change in anxiety and depression assessed by the Hospital Anxiety and Depression Scale. [Time frame: Baseline, Month 12.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 27 centers

• Beijing Chaoyang Hospital, Capital Medical University — Beijing
• Beijing Anzhen Hospital — Beijing
• Beijing Jishuitan Hospital — Beijing
• Beijing Hospital — Beijing
• Peking University International Hospital — Beijing
• Fujian Medical University Union Hospital — Fuzhou
• First Affiliated Hospital of Fujian Medical University — Fuzhou
• Zhangzhou Hospital of Fujian Province — Zhangzhou
• … and 19 more centers

Publications

• Dretzke J, Chuchu N, Agarwal R, Herd C, Chua W, Fabritz L, Bayliss S, Kotecha D, Deeks JJ, Kirchhof P, Takwoingi Y. Predicting recurrent atrial fibrillation after catheter ablation: a systematic review of prognostic models. Europace. 2020 May 1;22(5):748-760. doi: 10.1093/europace/euaa041. PMID 32227238
• Sanchez-de-la-Torre M, Gracia-Lavedan E, Benitez ID, Sanchez-de-la-Torre A, Moncusi-Moix A, Torres G, Loffler K, Woodman R, Adams R, Labarca G, Dreyse J, Eulenburg C, Thunstrom E, Glantz H, Peker Y, Anderson C, McEvoy D, Barbe F. Adherence to CPAP Treatment and the Risk of Recurrent Cardiovascular Events: A Meta-Analysis. JAMA. 2023 Oct 3;330(13):1255-1265. doi: 10.1001/jama.2023.17465. PMID 37787793
• Caples SM, Mansukhani MP, Friedman PA, Somers VK. The impact of continuous positive airway pressure treatment on the recurrence of atrial fibrillation post cardioversion: A randomized controlled trial. Int J Cardiol. 2019 Mar 1;278:133-136. doi: 10.1016/j.ijcard.2018.11.100. Epub 2018 Nov 20. PMID 30522886
• Hunt TE, Traaen GM, Aakeroy L, Bendz C, Overland B, Akre H, Steinshamn S, Loennechen JP, Hegbom F, Broch K, Lie OH, Lyseggen E, Haugaa KH, Gullestad L, Anfinsen OG. Effect of continuous positive airway pressure therapy on recurrence of atrial fibrillation after pulmonary vein isolation in patients with obstructive sleep apnea: A randomized controlled trial. Heart Rhythm. 2022 Sep;19(9):1433-1441. PMID 35716856
• Zhou Y, Yan M, Yuan J, Wang Y, Qiao S. Continuous Positive Airway Pressure Treatment Decreases the Risk of Atrial Fibrillation Recurrence in Patients with Obstructive Sleep Apnea after Radiofrequency Ablation. Int Heart J. 2022 Jul 30;63(4):716-721. doi: 10.1536/ihj.22-129. Epub 2022 Jul 14. PMID 35831157
• Holmqvist F, Guan N, Zhu Z, Kowey PR, Allen LA, Fonarow GC, Hylek EM, Mahaffey KW, Freeman JV, Chang P, Holmes DN, Peterson ED, Piccini JP, Gersh BJ; ORBIT-AF Investigators. Impact of obstructive sleep apnea and continuous positive airway pressure therapy on outcomes in patients with atrial fibrillation-Results from the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT- PMID 25965712
• Deng F, Raza A, Guo J. Treating obstructive sleep apnea with continuous positive airway pressure reduces risk of recurrent atrial fibrillation after catheter ablation: a meta-analysis. Sleep Med. 2018 Jun;46:5-11. doi: 10.1016/j.sleep.2018.02.013. Epub 2018 Mar 22. PMID 29773211
• de Heide J, Kock-Cordeiro DBM, Bhagwandien RE, Hoogendijk MG, van der Meer KC, Wijchers SA, Szili-Torok T, Zijlstra F, Lenzen MJ, Yap SC. Impact of undiagnosed obstructive sleep apnea on atrial fibrillation recurrence following catheter ablation (OSA-AF study). Int J Cardiol Heart Vasc. 2022 Mar 24;40:101014. doi: 10.1016/j.ijcha.2022.101014. eCollection 2022 Jun. PMID 35663451

Identifiers

NCT: NCT07444372 · KS2025046 · 2024ZD0529100

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗