Sleep breathing tests before and after ablation for atrial fibrillation
Records sleep in adults with paroxysmal atrial fibrillation having a heart ablation.
Key facts
- Who runs it
- Primula Clinics
- Where
- Grodzisk Mazowiecki, PolandSee the site
- Trial code
- Registry title
- Impact of Atrial Fibrillation Ablation on Sleep Parameters.
- Status
- Recruiting
- People taking part
- 100 people, planned
- Started
- 20 Mar 2025
- Planned end
- 28 Feb 2026
- Type of study
- Observational
- Record updated
- 2 December 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with atrial fibrillation who are scheduled for their first catheter ablation and have at least one risk factor for sleep apnea.
- Age
- 18 years or older
- Sex
- Men and women can join
- Disease stage
- Atrial fibrillation (paroxysmal) with catheter ablation (pulmonary vein isolation) scheduled; this must be the first ablation
- Earlier treatment
- No earlier atrial fibrillation ablation; the study includes only patients having ablation for the first time
Main reasons for not taking part
- No sleep apnea risk factors
- Had an atrial fibrillation ablation before
The registry criteria, word for word
Show all 3 criteriaShow less
Who can take part
- 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
Who cannot take part
- Absence of predefined sleep apnea risk factors
Where in Poland
- Primula ClinicsGrodzisk Mazowiecki, PolandContact: Paweł Basiukiewicz, MD, PhDTaking people
About the trial
What the trial wants to find out
Assessment of Sleep Parameters Using Polygraphy in Patients with Paroxysmal Atrial Fibrillation Qualified for Pulmonary Vein Isolation - A Prospective Observational Study: Afib Ablation and Hypopnea Index - The "AAHI" Study
Read full original descriptionShow less
Principal Investigator:
Dr. Paweł Basiukiewicz, MD, PhD
Study Sponsor:
Primula Clinics sp. z o.o. Żyrardowska 31, 05-825 Grodzisk Mazowiecki, Poland NIP (Tax ID): 529 183 03 11
Dear Sir/Madam,
You have been invited to participate in a scientific study aimed at assessing sleep parameters in patients with atrial fibrillation undergoing rhythm-control therapy. Please read this document carefully before deciding whether to take part in the study. If you have any questions, please contact the principal investigator.
Study Objective:
To assess sleep parameters using polygraphy in the course of treatment of patients with paroxysmal atrial fibrillation qualified for pulmonary vein isolation.
Study Procedures:
The study involves four polygraphic sleep studies (two before and two after atrial fibrillation ablation), each conducted at least 7 days apart.
The polygraphic studies will record the following parameters: pulse oximetry, heart rate, respiratory movements of the chest, and airflow through the anterior nares.
The study includes only patients undergoing atrial fibrillation ablation for the first time.
Risks and Benefits:
The study is non-invasive and does not involve any direct health risks. Participation will not affect your treatment process, but it may provide valuable information about your health status.
Voluntary Participation:
Participation in the study is entirely voluntary. You may withdraw from the study at any time without providing a reason and without any impact on your ongoing medical treatment.
Personal Data Protection (GDPR):
In accordance with Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 (General Data Protection Regulation - GDPR):
The data controller is Primula Clinics sp. z o.o.
Personal data will be processed solely for the purpose of conducting this study.
Data will be stored no longer than required by law or necessary for the research purposes.
You have the right to access your data, request its correction, deletion, restriction of processing, and to object to data processing.
All data will be protected against unauthorized access.
The group in the trial
- Afib scheduled for PVI, at least one risk factor for obstructive sleep apnea.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Assessment of Sleep Parameters Using Polygraphy in Patients With Paroxysmal Atrial Fibrillation Qualified for Pulmonary Vein Isolation - A Prospective Observational Study (AAHI Study)
- Plain-language title
- Sleep breathing tests before and after ablation for atrial fibrillationGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 2 December 2025