Actively Recruiting
Value of Screening and Treatment of Sleep Apnea-Hypopnea Syndrome in the Management of Atrial Fibrillation Ablation Candidates
Led by Hospital San Carlos, Madrid · Updated on 2025-09-15
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the value of screening for Sleep Apnea-Hypopnea Syndrome (SAHS) and its treatment in managing patients with atrial fibrillation (AF) who have not responded to antiarrhythmic drugs and may be candidates for ablation. This prospective, non-randomized cohort study aims to determine whether identifying and treating SAHS can improve heart rhythm outcomes and potentially reduce the need for AF ablation. The study focuses on patients with paroxysmal or persistent AF who have recurrent symptoms despite medication and have no prior SAHS diagnosis. Participants first complete a questionnaire to assess their risk for SAHS. Those at low risk follow standard AF care, while those at intermediate or high risk undergo home respiratory polygraphy and continuous heart rhythm monitoring using a Kardia recorder. Patients diagnosed with SAHS receive treatment based on usual care practices such as lifestyle changes or CPAP therapy. The study monitors heart rhythm and sleep apnea measures before and after SAHS treatment to evaluate changes and their impact on AF symptoms. After three months, the need for AF ablation is reassessed, and patients who remain symptomatic despite treatment may proceed to ablation. Throughout the study, participants regularly record their heart rhythm and undergo follow-up sleep studies to assess changes in apnea severity and arrhythmia. Researchers compare arrhythmic load over six months and analyze outcomes after ablation for those who require it. The study includes ongoing monitoring of SAHS treatment and arrhythmia for up to one year, with the goal of understanding how managing SAHS affects AF outcomes and ablation candidacy.
CONDITIONS
Brief Title
Value of Screening and Treatment of SAHS in the Management of AF Ablation Candidates
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Age 18 years or older
You will not qualify if you...
- Patients younger than 18 years
- Pregnant women
- Doubts about the patient's ability to perform home respiratory polygraphy
- Doubts about the patient's ability to use the Kardia system for rhythm recording (smartphone required)
- Unavailability for follow-up at the study center for at least 1 year
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 week
Participants complete a Stop-Bang questionnaire and perform home respiratory polygraphy and cardiac rhythm recordings to assess risk and diagnose Sleep Apnea-Hypopnea Syndrome (SAHS).
1 visit to Pneumology Outpatient Department after home testing
Duration - At least 3 months
Participants diagnosed with SAHS receive treatment according to usual practice (dietary hygienic measures, CPAP, etc.) while continuing rhythm monitoring.
Regular use of home cardiac rhythm recorder; 1 follow-up respiratory polygraphy visit after 3 months
Duration - Immediately after treatment period
After 3 months of treatment, participants are reassessed for atrial fibrillation ablation eligibility based on symptom recurrence and arrhythmic load.
1 clinical visit for reassessment
Duration - Up to 12 months post-ablation
Participants who undergo ablation are monitored for arrhythmic load during a 3-month blinding period and up to one year post-ablation, continuing SAHS treatment as needed.
Periodic visits during 3-month blinding period and follow-up visits up to one year
Trial Site Locations
Total: 1 location
1
Hospital Clínico San Carlos
Madrid, Madrid, Spain, 28040
Actively Recruiting
Research Team
N
Nicasio Pérez-Castellano, MD PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
PREVENTION
Number of Arms
2
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