Actively Recruiting
Impact of Atrial Fibrillation Ablation on Sleep Parameters.
Led by Primula Clinics · Updated on 2025-12-02
100
Participants Needed
1
Research Sites
49 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 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.
CONDITIONS
Official Title
Impact of Atrial Fibrillation Ablation on Sleep Parameters.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of atrial fibrillation (AFib) and scheduled catheter ablation
- Presence of at least one obstructive sleep apnea risk factor such as hypertension, male sex, BMI over 25, diabetes, excessive daytime sleepiness, or snoring
You will not qualify if you...
- Absence of predefined sleep apnea risk factors
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Primula Clinics
Grodzisk Mazowiecki, Poland, 05-825
Actively Recruiting
Research Team
P
Paweł S Basiukiewicz, MD, PhD
CONTACT
P
Piotr Futyma, MD, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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