Effect of pulmonary vein isolation on sleep breathing in people with paroxysmal atrial fibrillation
Assessment of Sleep Parameters Using Polygraphy in Patients With Paroxysmal Atrial Fibrillation Qualified for Pulmonary Vein Isolation - A Prospective Observational Study (AAHI Study)
Primula Clinics · NCT07259200
This study will test whether pulmonary vein isolation (a common AF ablation) changes sleep breathing measurements in people with paroxysmal atrial fibrillation who have risk factors for sleep apnea.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Primula Clinics (other) |
| Locations | 1 site (Grodzisk Mazowiecki) |
| Trial ID | NCT07259200 on ClinicalTrials.gov |
What this trial studies
This is a prospective observational study enrolling adults with paroxysmal atrial fibrillation who are scheduled for pulmonary vein isolation. Participants will undergo four polygraphic sleep recordings at defined timepoints before and after the ablation to measure hypopnea index and other sleep parameters. Clinical data on AF episodes and obstructive sleep apnea risk factors will be collected alongside routine care without introducing experimental treatments. Sleep breathing metrics will be compared over time to see if rhythm-control therapy is associated with measurable changes in sleep-disordered breathing.
Who should consider this trial
Good fit: Adults with paroxysmal atrial fibrillation scheduled for pulmonary vein isolation who have at least one risk factor for obstructive sleep apnea (for example, hypertension, male sex, BMI > 25, diabetes, excessive daytime sleepiness, or snoring).
Not a fit: People without OSA risk factors, those with persistent rather than paroxysmal AF, or those unable to attend in-person polygraphic testing are unlikely to benefit from this observational protocol.
Why it matters
Potential benefit: If results show improved sleep parameters after ablation, clinicians may better predict which patients could see sleep benefits from rhythm-control therapy.
How similar studies have performed: Prior observational work has reported that restoring sinus rhythm can improve sleep-disordered breathing in some patients, but findings are variable and high-quality randomized data are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria (all must be met): * Diagnosis of atrial fibrillation (AFib) and scheduled catheter ablation. * Presence of at least one OSA risk factor: hypertension, male sex, BMI \> 25, diabetes, excessive daytime sleepiness, snoring. Exclusion Criteria: \- Absence of predefined sleep apnea risk factors.
Where this trial is running
Grodzisk Mazowiecki
- Primula Clinics — Grodzisk Mazowiecki, Poland (RECRUITING)
Study contacts
- Principal investigator: Paweł S Basiukiewicz, MD, PhD — Primula Clinics
- Study coordinator: Paweł S Basiukiewicz, MD, PhD
- Email: pbasiukiewicz@gmail.com
- Phone: +48 698612826
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.
Conditions: Atrial Fibrillation, OSA - Obstructive Sleep Apnea, Pulmonary Vein Isolation, atrial fibrillation, sleep apnea, sleep apnoea, ablation, pulmonary vein isolation