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Recruiting NCT06542263

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

— Observational Atrial Fibrillation Continuous Positive Airway Pressure Obstructive Sleep Apnea Recurrence

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CPAP.
Who it may be relevant to
Registry conditions: Atrial Fibrillation, Continuous Positive Airway Pressure, Obstructive Sleep Apnea, Recurrence. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • AF recurrence after ablation [Time frame: At 3, 6, 9, and 12 months after AF ablation]
  • AF burden after ablation AF burden after ablation AF burden after ablation [Time frame: At 3, 6, 9, and 12 months after AF ablation]
Secondary outcome measures (4)
  • The recurrence of AF after combination with antiarrhythmic drugs [Time frame: At 3, 6, 9, and 12 months after AF ablation]
  • AF burden after combination with antiarrhythmic drugs [Time frame: At 3, 6, 9, and 12 months after AF ablation]
  • SF-36 [Time frame: At 3 and 12 months after AF ablation]
  • Euro-QoL5D Survey Scoring [Time frame: At 3 and 12 months after AF ablation]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • The Second Affiliated Hospital of Soochow University — Suzhou

Identifiers

NCT: NCT06542263 · JD-LK2024034-IR01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗