Clinical Study on the Effect of CPAP on AF Recurrence After Catheter Ablation in Patients with AF and OSA

Clinical Study on the Effect of Continuous Positive Airway Pressure Ventilation on Atrial Fibrillation Recurrence After Catheter Ablation in Patients with Atrial Fibrillation and Obstructive Sleep Apnea

Atrial fibrillation (AF) is the most common sustained arrhythmia in clinical practice, significantly increasing the risks of death, stroke, heart failure, cognitive impairment, and dementia, thus severely impacting patients' quality of life. However, for AF patients with concomitant cardiovascular risk factors, particularly those with obstructive sleep apnea (OSA), the success rate of catheter ablation is significantly reduced. Continuous positive airway pressure (CPAP) is currently an effective treatment for OSA, effectively correcting nocturnal intermittent hypoxia and fragmented sleep caused by OSA. However, the effect of CPAP therapy on AF recurrence in patients with OSA undergoing catheter ablation remains controversial. Faced with conflicting research findings, our team recently conducted a meta-analysis (registration number CRD42023398588) to assess the impact of CPAP on AF recurrence post catheter ablation in patients with AF and OSA, suggesting that CPAP significantly reduces AF recurrence post catheter ablation (RR = 0.58, P < 0.01). However, considering the limited number of included studies, potential bias risks, and confounding factors, our meta-analysis results await further confirmation through real-world studies by our team. Therefore, our team plans to conduct further research on the impact of CPAP on AF recurrence post catheter ablation in patients with moderate to severe OSA, aiming to provide clinical guidance for the treatment of AF in patients with moderate to severe OSA.

Study Overview

• Status: Recruiting
• Conditions: Recurrence; Atrial Fibrillation; Obstructive Sleep Apnea; Observational Study; Continuous Positive Airway Pressure
• Intervention / Treatment: Device: CPAP

• Study Type: Observational
• Enrollment (Estimated): 224

Contacts and Locations

• Study Contact: Name: Hui Li; Phone Number: 0512-67784077; Email: lihuifry@suda.edu.cn
• Study Contact Backup: Name: WenYan Hua; Phone Number: 0512-67783682; Email: sdfeyec@163.com

Study Locations

• China
  • Jinagsu
    • Suzhou, Jinagsu, China, 215004
      • Recruiting
      • The Second Affiliated Hospital of Soochow University
      • Contact: Feng Li; Phone Number: 17512576836; Email: lifeng2468@suda.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Clinical diagnosis of AF combined with moderate to severe OSA (OSA diagnostic criteria: apnea hypopnea index (AHI) greater than 15/hour, and at least 80% of all events are respiratory sleep obstructive events; AF includes persistent atrial fibrillation and paroxysmal atrial fibrillation)

Description

Inclusion Criteria:

1. Clinical diagnosis of AF combined with moderate to severe OSA (OSA diagnostic criteria: apnea hypopnea index (AHI) greater than 15/hour, and at least 80% of all events are respiratory sleep obstructive events; AF includes persistent atrial fibrillation and paroxysmal atrial fibrillation)
2. Age ≥ 18 years old
3. The patient voluntarily participates in the project and signs informed consent
4. All patients undergo overnight sleep pressure titration at the sleep center to determine the minimum pressure value for continuous positive airway pressure ventilation at home. All patients are required to undergo CPAP treatment at home at least 5 days a week, with each session lasting at least 4 hours

Exclusion Criteria:

1. Patients with neuromuscular disorders, pulmonary hypopnea, and severe lung diseases
2. Preoperative confirmation of thrombus in the left atrium
3. The patient has no desire for conversion
4. Secondary atrial fibrillation (hyperthyroidism, tumors, etc.)
5. Individuals with contraindications to anticoagulants
6. Left atrial diameter (LAD) exceeding 60mm (2D echocardiography long axis section data)
7. Pregnant women
8. History of myocardial infarction, percutaneous coronary intervention, and cardiac surgery in the past three months
9. Stroke or transient ischemic attack in the past six months
10. After artificial valve implantation surgery
11. Severe renal insufficiency (creatinine Cr>2.5mg/dl or>221umol/L, or glomerular filtration rate eGFR<30ml/min/1.73m2)
12. Acute diseases or active infections that occur before surgery, recorded as pain, fever, positive blood culture, and/or leukocytosis, or have been treated with antibiotics.
13. Expected survival period<1 year

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
non-CPAP group; The non-CPAP group underwent catheter ablation and conventional treatment for AF combined with OSA	Device: CPAP; For the non-CPAP group, the intervention includes catheter ablation and conventional treatment for AF combined with OSA; For the CPAP group, the intervention includes catheter ablation and CPAP treatment for AF combined with OSA
CPAP group; The CPAP group underwent catheter ablation and CPAP treatment for AF combined with OSA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AF recurrence after ablation	AF recurrence after ablation via Surface electrocardiogram and 24-hour dynamic electrocardiogram examination. If there are symptoms, seek medical attention at any time for electrocardiogram examination	At 3, 6, 9, and 12 months after AF ablation
AF burden after ablation AF burden after ablation AF burden after ablation	AF burden after ablation via 24-hour dynamic electrocardiogram examination AF burden after ablation via 24-hour dynamic electrocardiogram examinatio AF burden after ablation via 24-hour dynamic electrocardiogram examinatio	At 3, 6, 9, and 12 months after AF ablation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The recurrence of AF after combination with antiarrhythmic drugs	The recurrence of AF after combination with antiarrhythmic drugs via Surface electrocardiogram and 24-hour dynamic electrocardiogram examination. If there are symptoms, seek medical attention at any time for electrocardiogram examination	At 3, 6, 9, and 12 months after AF ablation
AF burden after combination with antiarrhythmic drugs	AF burden after combination with antiarrhythmic drugs via 24-hour dynamic electrocardiogram examinatio	At 3, 6, 9, and 12 months after AF ablation
SF-36	SF-36 with standard scores ranging from 0 to 100. The higher the score, the better the health status	At 3 and 12 months after AF ablation
Euro-QoL5D Survey Scoring	Euro-QoL5D survey questionnaire is between 0 and 100, with higher scores indicating better health status	At 3 and 12 months after AF ablation

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital of Soochow University

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: August 4, 2024
• First Submitted That Met QC Criteria: August 4, 2024
• First Posted (Actual): August 7, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 20, 2025
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Disease Attributes; Respiratory Tract Diseases; Arrhythmias, Cardiac; Respiration Disorders; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Recurrence; Atrial Fibrillation; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: JD-LK2024034-IR01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

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