Start CPAP Therapy in Obstructive Sleep Apnea Patients After Atrial Fibrillation Ablation (STOP-AFib)

April 20, 2026 updated by: Beijing Anzhen Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

658

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100730
        • Beijing Hospital
        • Contact:
        • Principal Investigator:
          • Wei Gong, Professor
      • Beijing, Beijing Municipality, China, 102206
        • Peking University International Hospital
        • Contact:
        • Principal Investigator:
          • Xuezhi Chen, Professor
      • Beijing, Beijing Municipality, China, 100035
        • Beijing Jishuitan Hospital
        • Contact:
        • Principal Investigator:
          • Yang Cheng, Professor
      • Beijing, Beijing Municipality, China, 100029
        • Beijing Anzhen Hospital
        • Contact:
        • Principal Investigator:
          • Jiang Xie, Professor
        • Principal Investigator:
          • Shaoping Nie, Professor
        • Principal Investigator:
          • Deyong Long, Professor
    • Fujian
      • Fuzhou, Fujian, China, 350004
        • First Affiliated Hospital of Fujian Medical University
        • Contact:
        • Principal Investigator:
          • Ningfang Lian, Professor
    • Hebei
      • Langfang, Hebei, China, 065000
        • Langfang People's Hospital
        • Contact:
        • Principal Investigator:
          • Zengming Xue, Professor
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150086
        • Second Affiliated Hospital of Harbin Medical University
        • Contact:
        • Principal Investigator:
          • Shuo Zhang, Professor
    • Hubei
      • Wuhan, Hubei, China, 430014
        • Wuhan No. 1 Hospital
        • Contact:
        • Principal Investigator:
          • Junhua Mei, Professor
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • The First Affiliated Hospital of Nanjing Medical University
        • Contact:
        • Principal Investigator:
          • Ning Ding, Professor
    • Liaoning
      • Dalian, Liaoning, China, 116011
        • First Affiliated Hospital of Dalian Medical University
        • Contact:
        • Principal Investigator:
          • Haiying Tang, Professor
      • Shenyang, Liaoning, China, 110001
        • First Affiliated Hospital of China Medical University
        • Contact:
        • Principal Investigator:
          • Wenyang Li, Professor
    • Shanxi
      • Taiyuan, Shanxi, China, 030001
        • Second Hospital of Shanxi Medical University
        • Contact:
        • Principal Investigator:
          • Bei Wang, Professor
    • Zhejiang
      • Ningbo, Zhejiang, China, 315010
        • First Affiliated Hospital of Ningbo University
        • Contact:
        • Principal Investigator:
          • Maoqing Dong, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CPAP Group
Usual care combined with CPAP therapy.
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 days.
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.
Active Comparator: Usual Care Group
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of freedom from atrial arrhythmia recurrence.
Time Frame: Within 12 months

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of any documented atrial arrhythmia (AF/AFL/AT) lasting ≥30 seconds.
Time Frame: Within 12 months (after a 3-month blanking period).
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).
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).
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).
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).
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).
Within 12 months (after a 3-month blanking period).
Proportion of patients undergoing repeat catheter ablation.
Time Frame: Within 12 months.
Within 12 months.
AF burden
Time Frame: Within 12 months.
Within 12 months.
Change in quality of life assessed by the Atrial Fibrillation Effect on Quality-of-Life questionnaire.
Time Frame: Baseline, Month 12.
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.
Time Frame: Baseline, Month 12.
Scores for both the anxiety and depression subscales range from 0 to 21, where higher scores indicate worse anxiety and depression.
Baseline, Month 12.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Anzhen Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

January 31, 2029

Study Completion (Estimated)

January 31, 2029

Study Registration Dates

First Submitted

February 25, 2026

First Submitted That Met QC Criteria

February 25, 2026

First Posted (Actual)

March 2, 2026

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 20, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KS2025046
  • 2024ZD0529100 (Other Grant/Funding Number: Development Center for Medical Science & Technology National Health Commission of the People's Republic of China)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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