Effect of CPAP on Atrial Fibrillation Recurrence After Catheter Ablation
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
This study is testing if using CPAP therapy for sleep apnea can help prevent atrial fibrillation from coming back in patients who have had a heart procedure to treat it.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 224 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Second Affiliated Hospital of Soochow University Academic / other |
| Locations | 1 site (Suzhou, Jinagsu) |
| Trial ID | NCT06542263 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the impact of continuous positive airway pressure (CPAP) therapy on the recurrence of atrial fibrillation (AF) in patients who also have obstructive sleep apnea (OSA) after undergoing catheter ablation. It aims to clarify the controversial findings regarding the effectiveness of CPAP in reducing AF recurrence in this patient population. Participants will be required to have a clinical diagnosis of AF and moderate to severe OSA, and they will undergo CPAP treatment at home for at least 5 days a week. The study will assess the relationship between CPAP adherence and AF recurrence rates post-ablation.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a clinical diagnosis of atrial fibrillation and moderate to severe obstructive sleep apnea.
Not a fit: Patients with neuromuscular disorders, severe lung diseases, or secondary atrial fibrillation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into improving AF management in patients with OSA, potentially reducing the risk of AF recurrence.
How similar studies have performed: Previous studies have shown mixed results regarding the impact of CPAP on AF recurrence, making this investigation both relevant and necessary.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Suzhou, Jinagsu
- The Second Affiliated Hospital of Soochow University — Suzhou, Jinagsu, China (Recruiting)
Study contacts
- Study coordinator: Hui Li
- Email: lihuifry@suda.edu.cn
- Phone: 0512-67784077
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.