Impact of Atrial Fibrillation Ablation on Sleep Parameters.
Recruiting · NCT07259200 · Observational (researchers observe without assigning treatment) · Lead sponsor: Primula Clinics
View the official record on ClinicalTrials.gov →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.
Who can take part
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 it is running
1 location listed.
- Primula Clinics - Grodzisk Mazowiecki, Poland