RecruitingNCT07259200

Impact of Atrial Fibrillation Ablation on Sleep Parameters.

Assessment of Sleep Parameters Using Polygraphy in Patients With Paroxysmal Atrial Fibrillation Qualified for Pulmonary Vein Isolation - A Prospective Observational Study (AAHI Study)


Sponsor

Primula Clinics

Enrollment

100 participants

Start Date

Mar 20, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at whether treating atrial fibrillation (AFib — an irregular heartbeat) with a procedure called catheter ablation improves sleep quality, particularly in patients who also have risk factors for sleep apnea. **You may be eligible if...** - You have been diagnosed with atrial fibrillation and are scheduled for catheter ablation - You have at least one sleep apnea risk factor: high blood pressure, being male, BMI over 25, diabetes, excessive daytime sleepiness, or snoring **You may NOT be eligible if...** - You have none of the defined sleep apnea risk factors - You have conditions that prevent participation in sleep monitoring assessments Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Primula Clinics

Grodzisk Mazowiecki, Poland

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NCT07259200


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