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

NCT07444372 | Not Yet Recruiting

• 2 other identifiers: KS20250462024ZD0529100
• Study Type: interventional
• Target: 658
• Locations: 1 country
• Sites: 13

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.

Conditions

Obstructive Sleep Apnea; Sleep Disorder (Disorder); Atrial Fibrillation (AF); Sleep Disordered Breathing (SDB); Arrhythmia; Continuous Positive Airway Pressure

Keywords

Obstructive Sleep Apnea; Continuous Positive Airway Pressure; Atrial Fibrillation; Ablation of atrial fibrillation; Sleep Disordered Breathing; Clinical Trial; Catheter Ablation

Outcome Measures

Primary Outcomes (1)

• Incidence of freedom from atrial arrhythmia recurrence.

  Recurrence is defined as a composite of: 1. Any documented atrial arrhythmia (AF / Atrial Tachycardia \[AT\] / Atrial Flutter \[AFL\]) lasting 30 seconds after a 3-month blanking period; 2. Use of Class I or III AADs after the 3-month blanking period; 3. Cardioversion performed after the 3-month blanking period; 4. Repeat catheter ablation performed at any time.

  Within 12 months

Secondary Outcomes (10)

• 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).

• 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).

Study Arms (2)

CPAP Group

EXPERIMENTAL

Usual care combined with CPAP therapy.

Device: Continuous Positive Airway Pressure (CPAP); Other: Usual Care

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.

Other: Usual Care

Interventions

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.

CPAP Group

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.

CPAP Group; Usual Care Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

Study Sites (13)

Beijing Anzhen Hospital

Beijing, Beijing Municipality, 100029, China

Location

Beijing Jishuitan Hospital

Beijing, Beijing Municipality, 100035, China

Location

Beijing Hospital

Beijing, Beijing Municipality, 100730, China

Location

Peking University International Hospital

Beijing, Beijing Municipality, 102206, China

Location

First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350004, China

Location

Langfang People's Hospital

Langfang, Hebei, 065000, China

Location

Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150086, China

Location

Wuhan No. 1 Hospital

Wuhan, Hubei, 430014, China

Location

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location

First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, 116011, China

Location

First Affiliated Hospital of China Medical University

Shenyang, Liaoning, 110001, China

Location

Second Hospital of Shanxi Medical University

Taiyuan, Shanxi, 030001, China

Location

First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, 315010, China

Location

Related Publications (10)

• 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 BACKGROUND

• 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 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.

  PMID: 30522886 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.

  PMID: 35716856 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.

  PMID: 35831157 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.

  PMID: 25965712 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.

  PMID: 29773211 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.

  PMID: 35663451 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.

  PMID: 39537150 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. Erratum In: Circulation. 2022 Mar 22;145(12):e775. doi: 10.1161/CIR.0000000000001043.

  PMID: 34148375 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Wake Disorders; Atrial Fibrillation; Sleep Apnea Syndromes; Arrhythmias, Cardiac

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Heart Diseases; Cardiovascular Diseases; Pathologic Processes

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Central Study Contacts

Jiang Xie, Professor

CONTACT

+86 64456360; frank782008@aliyun.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2026
• First Posted: March 2, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): January 31, 2029
• Study Completion (Estimated): January 31, 2029
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (13)