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

NCT06542263 | Recruiting DMC

• 1 other identifier: JD-LK2024034-IR01
• Study Type: observational
• Target: 224
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrial Fibrillation; Continuous Positive Airway Pressure; Obstructive Sleep Apnea; Recurrence; Observational Study

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• The recurrence of AF after combination with antiarrhythmic drugs

  At 3, 6, 9, and 12 months after AF ablation

• AF burden after combination with antiarrhythmic drugs

  At 3, 6, 9, and 12 months after AF ablation

• SF-36

  At 3 and 12 months after AF ablation

• Euro-QoL5D Survey Scoring

  At 3 and 12 months after AF ablation

Study Arms (2)

non-CPAP group

The non-CPAP group underwent catheter ablation and conventional treatment for AF combined with OSA

Device: CPAP

CPAP group

The CPAP group underwent catheter ablation and CPAP treatment for AF combined with OSA

Interventions

CPAP DEVICE

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

non-CPAP group

Eligibility Criteria

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

You may qualify if:

• 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)
• Age ≥ 18 years old
• The patient voluntarily participates in the project and signs informed consent
• 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

You may not qualify if:

• Patients with neuromuscular disorders, pulmonary hypopnea, and severe lung diseases
• Preoperative confirmation of thrombus in the left atrium
• The patient has no desire for conversion
• Secondary atrial fibrillation (hyperthyroidism, tumors, etc.)
• Individuals with contraindications to anticoagulants
• Left atrial diameter (LAD) exceeding 60mm (2D echocardiography long axis section data)
• Pregnant women
• History of myocardial infarction, percutaneous coronary intervention, and cardiac surgery in the past three months
• Stroke or transient ischemic attack in the past six months
• After artificial valve implantation surgery
• Severe renal insufficiency (creatinine Cr\>2.5mg/dl or\>221umol/L, or glomerular filtration rate eGFR\<30ml/min/1.73m2)
• 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.
• Expected survival period\<1 year

Sponsors & Collaborators

• Second Affiliated Hospital of Soochow University: lead

Study Sites (1)

The Second Affiliated Hospital of Soochow University

Suzhou, Jinagsu, 215004, China

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Sleep Apnea, Obstructive; Recurrence

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Disease Attributes

Central Study Contacts

Hui Li

CONTACT

0512-67784077; lihuifry@suda.edu.cn

WenYan Hua

CONTACT

0512-67783682; sdfeyec@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2024
• First Posted: August 7, 2024
• Study Start: August 9, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: January 23, 2025

Record last verified: 2024-08

Locations

CN (1)