Screening and treating sleep apnea in people with atrial fibrillation who are candidates for ablation
Official title: Value of Screening and Treatment of Sleep Apnea-Hypopnea Syndrome in the Management of Atrial Fibrillation Ablation Candidates
Run by Hospital San Carlos, Madrid · NCT04606693 · Data updated 2026-11-12
This program will try screening for and treating sleep apnea in adults with atrial fibrillation that persists despite medication to see if treating sleep apnea lowers arrhythmia burden and reduces the need for ablation.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Hospital San Carlos, Madrid Academic / other |
| Locations | 1 site (Madrid, Madrid) |
| Status | Recruiting |
| Started | November 5, 2020 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | September 15, 2025 |
| Trial ID | NCT04606693 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with paroxysmal or persistent atrial fibrillation that recurs despite at least one class I or III antiarrhythmic and no prior diagnosis of sleep apnea are eligible.
✕Probably not a fit
Patients without sleep-disordered breathing, those unable to perform home testing or use the smartphone-based recorder, or those whose AF is unrelated to sleep apnea may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, non-randomized cohort that uses the Stop-Bang questionnaire to stratify AF patients by risk of sleep apnea. Patients at intermediate or high risk receive home respiratory polygraphy and use a Kardia recorder to track cardiac rhythm before and during treatment. Those diagnosed with sleep apnea receive standard therapies (lifestyle measures, CPAP, etc.) from Pneumology and continue rhythm monitoring for three months. After follow-up the arrhythmic load is re-evaluated to determine which patients still require ablation versus those who can be managed with follow-up.
Why it matters
Potential benefit: If successful, treating sleep apnea could reduce arrhythmia burden and lower the number of patients who need AF ablation.
How similar studies have gone: Observational studies have suggested that treating obstructive sleep apnea can reduce AF recurrence and improve outcomes, though randomized evidence is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with paroxysmal or persistent atrial fibrillation * Recurrent atrial fibrillation despite treatment with at least one class I or III antiarrhythmic * No previous diagnosis of apnea-hypopnea syndrome Exclusion Criteria: * Patients \<18 years * Pregnant women * Doubts about the patient's ability to perform a home respiratory polygraphy * Doubts about the patient's ability to acquire rhythm records with the Kardia system (smartphone required) * Unavailability for follow-up at our center for at least 1 year.
Where it's running
-
Hospital Clínico San Carlos
Madrid, Madrid, Spain Recruiting
Study contacts
- Study coordinator: Nicasio Pérez-Castellano, MD PhD
- Email: nicasio.perez@salud.madrid.org
- Phone: +34913303000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.