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| ID | Type | Description | Link |
|---|---|---|---|
| 2024ZD0529100 | Other Grant/Funding Number | Development Center for Medical Science & Technology National Health Commission of the People's Republic of China |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CPAP Group | Experimental | Usual care combined with CPAP therapy. |
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| Usual Care Group | Active Comparator | Standard of care for atrial fibrillation and usual care for OSA (health education). Researchers advise participants to visit sleep centers or pulmonology departments for further assessment/treatment at their own discretion, but do not intervene in their choice of OSA therapy or provide the study CPAP device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Positive Airway Pressure (CPAP) | Device | 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 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of freedom from atrial arrhythmia recurrence. | Recurrence is defined as a composite of:
| Within 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of any documented atrial arrhythmia (AF/AFL/AT) lasting ≥30 seconds. | Within 12 months (after a 3-month blanking period). | |
| Incidence of documented AF lasting ≥30 seconds. | Within 12 months (after a 3-month blanking period). |
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Inclusion Criteria:
Patients must meet all of the following conditions to be eligible for the study:
Exclusion Criteria:
Patients meeting any of the following criteria will be excluded from the study:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiang Xie, Professor | Contact | +86 64456360 | frank782008@aliyun.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Chaoyang Hospital, Capital Medical University | Not yet recruiting | Beijing | Beijing Municipality | 100020 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32227238 | Background | 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. | |
| 37787793 | Background |
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| Usual Care | Other | 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. |
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| Incidence of documented AT lasting ≥30 seconds. | Within 12 months (after a 3-month blanking period). |
| Incidence of documented AFL lasting ≥30 seconds. | Within 12 months (after a 3-month blanking period). |
| Proportion of patients using Class I or III antiarrhythmic drugs. | Within 12 months (after a 3-month blanking period). |
| Proportion of patients undergoing cardioversion. | Within 12 months (after a 3-month blanking period). |
| Proportion of patients undergoing repeat catheter ablation. | Within 12 months. |
| AF burden | Within 12 months. |
| Change in quality of life assessed by the Atrial Fibrillation Effect on Quality-of-Life questionnaire. | Scores range from 0 to 100, where higher scores indicate a better quality of life. | Baseline, Month 12. |
| Change in anxiety and depression assessed by the Hospital Anxiety and Depression Scale. | Scores for both the anxiety and depression subscales range from 0 to 21, where higher scores indicate worse anxiety and depression. | Baseline, Month 12. |
| Beijing Anzhen Hospital | Recruiting | Beijing | Beijing Municipality | 100029 | China |
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| Beijing Jishuitan Hospital | Not yet recruiting | Beijing | Beijing Municipality | 100035 | China |
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| Beijing Hospital | Not yet recruiting | Beijing | Beijing Municipality | 100730 | China |
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| Peking University International Hospital | Not yet recruiting | Beijing | Beijing Municipality | 102206 | China |
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| Fujian Medical University Union Hospital | Not yet recruiting | Fuzhou | Fujian | 350001 | China |
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| First Affiliated Hospital of Fujian Medical University | Not yet recruiting | Fuzhou | Fujian | 350004 | China |
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| Zhangzhou Hospital of Fujian Province | Not yet recruiting | Zhangzhou | Fujian | 363000 | China |
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| People's Hospital of Guangxi Zhuang Autonomous Region | Not yet recruiting | Nanning | Guangxi | 530021 | China |
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| Langfang People's Hospital | Not yet recruiting | Langfang | Hebei | 065000 | China |
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| Shijiazhuang Great Wall Hospital of Integrated Traditional Chinese and Western Medicine | Not yet recruiting | Shijiazhuang | Hebei | 050000 | China |
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| The Ninth Hospital of Xingtai | Not yet recruiting | Xingtai | Hebei | 055250 | China |
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| Second Affiliated Hospital of Harbin Medical University | Not yet recruiting | Harbin | Heilongjiang | 150086 | China |
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| The First Affiliated Hospital of Zhengzhou University | Not yet recruiting | Zhengzhou | Henan | 450052 | China |
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| Wuhan No. 1 Hospital | Not yet recruiting | Wuhan | Hubei | 430014 | China |
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| Wuhan Asia General Hospital | Not yet recruiting | Wuhan | Hubei | 430056 | China |
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| The Second Xiangya Hospital of Central South University | Not yet recruiting | Changsha | Hunan | 410011 | China |
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| The First Affiliated Hospital of Nanjing Medical University | Not yet recruiting | Nanjing | Jiangsu | 210029 | China |
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| The First Hospital of Jilin University | Not yet recruiting | Changchun | Jilin | 130021 | China |
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| First Affiliated Hospital of Dalian Medical University | Not yet recruiting | Dalian | Liaoning | 116011 | China |
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| First Affiliated Hospital of China Medical University | Not yet recruiting | Shenyang | Liaoning | 110001 | China |
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| Shengjing Hospital of China Medical University | Not yet recruiting | Shenyang | Liaoning | 110004 | China |
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| Shengli Oilfield Central Hospital | Not yet recruiting | Dongying | Shandong | 257034 | China |
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| Linyi People's Hospital | Not yet recruiting | Linyi | Shandong | 276003 | China |
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| Second Hospital of Shanxi Medical University | Not yet recruiting | Taiyuan | Shanxi | 030001 | China |
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| Tianjin Chest Hospital | Not yet recruiting | Tianjin | Tianjin Municipality | 300222 | China |
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| First Affiliated Hospital of Ningbo University | Not yet recruiting | Ningbo | Zhejiang | 315010 | China |
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| 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. |
| 30522886 | Background | 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. |
| 35716856 | Background | 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. doi: 10.1016/j.hrthm.2022.06.016. Epub 2022 Jun 16. |
| 35831157 | Background | 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. |
| 25965712 | Background | 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-AF). Am Heart J. 2015 May;169(5):647-654.e2. doi: 10.1016/j.ahj.2014.12.024. Epub 2015 Feb 7. |
| 29773211 | Background | 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. |
| 35663451 | Background | 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. |
| 39537150 | Background | Minami T, Yoshizawa T, Murase K, Komasa A, Aizawa T, Yamagami S, Tanaka M, Shizuta S, Sato S, Ono K, Hirai T, Kimura T, Chin K. Associations Among Sleep Apnea, Objective or Subjective Sleep Duration, and Recurrence of Atrial Fibrillation in Patients Who Undergo Radiofrequency Catheter Ablation for Persistent Atrial Fibrillation - A Prospective Observational Study. Circ J. 2025 Jan 24;89(2):184-194. doi: 10.1253/circj.CJ-24-0537. Epub 2024 Nov 12. |
| 34148375 | Background | Yeghiazarians Y, Jneid H, Tietjens JR, Redline S, Brown DL, El-Sherif N, Mehra R, Bozkurt B, Ndumele CE, Somers VK. Obstructive Sleep Apnea and Cardiovascular Disease: A Scientific Statement From the American Heart Association. Circulation. 2021 Jul 20;144(3):e56-e67. doi: 10.1161/CIR.0000000000000988. Epub 2021 Jun 21. |
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D012893 | Sleep Wake Disorders |
| D001281 | Atrial Fibrillation |
| D012891 | Sleep Apnea Syndromes |
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D045422 | Continuous Positive Airway Pressure |
| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
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