Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID04606693

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

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

Treatment

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

Reassessment and Possible Ablation

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

Follow-up After Ablation

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

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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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