Status:
RECRUITING
Clinical Study on the Effect of CPAP on AF Recurrence After Catheter Ablation in Patients with AF and OSA
Lead Sponsor:
Second Affiliated Hospital of Soochow University
Conditions:
Atrial Fibrillation
Continuous Positive Airway Pressure
Eligibility:
All Genders
18+ years
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 seve...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 9 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
224 Patients enrolled
Trial Details
Trial ID
NCT06542263
Start Date
August 9 2024
End Date
August 1 2026
Last Update
January 23 2025
Active Locations (1)
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1
The Second Affiliated Hospital of Soochow University
Suzhou, Jinagsu, China, 215004