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.

Study Title

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

2. Introduction and Study Rationale

Atrial fibrillation (AFib) is the most common cardiac arrhythmia and is associated with an increased risk of cardiovascular complications and reduced quality of life. Obstructive sleep apnea (OSA) frequently coexists with AFib and may influence both the course of the arrhythmia and the effectiveness of its treatment, including catheter ablation. It is known that atrial fibrillation may exacerbate obstructive sleep apnea through mechanisms such as the loss of atrioventricular synchrony, absence of the so-called "atrial kick," tachycardia, and fluid redistribution within the body during AFib episodes.

The aim of this study is to assess changes in sleep parameters, measured by polygraphy, during the treatment course of patients with atrial fibrillation who are qualified for pulmonary vein isolation.

3. Study Objective

To assess sleep parameters using polygraphy during the course of treatment of patients with paroxysmal atrial fibrillation qualified for pulmonary vein isolation.

4. Research Hypothesis

Sleep parameters assessed via polygraphy, particularly the Apnea-Hypopnea Index (AHI), change following rhythm-control therapy.

5. Study Population

Inclusion Criteria:

Patients with atrial fibrillation who have been previously qualified for AFib ablation.

Presence of at least one risk factor for sleep apnea from the following list: diabetes, hypertension, male sex, BMI > 25, neck circumference > 42 cm in women and > 45 cm in men, upper airway obstruction, history of snoring, daytime sleepiness or fatigue, or witnessed apneic events or choking episodes during sleep.

Exclusion Criteria:

Absence of sleep apnea risk factors.

Lack of consent to participate in the study.

Study Notes:

Polygraphic assessments will be performed as a standard procedure recommended in clinical guidelines, ensuring that the study does not interfere with routine patient care.

Therefore, the study maintains an observational, non-interventional character.

6. Study Procedures

1. Before the planned AFib ablation:

   Two polygraphic studies will be performed at least 7 days apart.

   Recorded channels: pulse oximetry, heart rate, respiratory movements of the chest and abdomen using respiratory inductance plethysmography (RIP) belts, and nasal airflow (pressure) through the anterior nares.

2. After AFib ablation:

   Two polygraphic studies will be performed, at least 7 days apart, beginning one month after the ablation procedure.

   The same recording channels as above will be used.

3. Routine recommendations:

   All standard-of-care procedures, including lifestyle modification advice and non-pharmacological interventions (e.g., initiation of CPAP therapy, if indicated), will be provided to each patient in accordance with routine clinical practice.

4. Ablation procedure:

The ablation is not part of the study. It is a pre-planned, routine clinical procedure scheduled prior to study screening.

7. Methodology

Polygraphic Studies:

Certified sleep-monitoring equipment will be used (Nox polygraph, Nox Medical).

Analysis will include AHI, oxygen saturation, heart rate, and respiratory pattern assessment.

Planned Study Population: Approximately 100 participants.

Study Duration: Recruitment period estimated at 6-12 months, with the possibility of extension and inclusion of additional centers if the necessary criteria are met.

Statistical Analysis:

Comparison of pre- and post-ablation sleep parameters using appropriate statistical tests (e.g., paired t-test for parametric data or Wilcoxon test for non-parametric data).

Endpoints: Statistically significant changes in sleep parameters (particularly AHI) recorded by polygraphy.

8. Ethics

The study is observational and does not interfere with standard patient treatment.

All participants will provide written informed consent after being informed about the purpose, course, and potential benefits of the study.

The study will be conducted in accordance with the Declaration of Helsinki and approved by the local bioethics committee.

9. Results and Application

The study results may provide insight into the potential effects of rhythm-control therapy on sleep parameters in patients with atrial fibrillation. This could contribute to a better understanding of the relationship between these two conditions and to optimizing patient management.

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.

Patients with AFib scheduled for pulmonary vein isolation.

Database with participants (DOB, HSAT data, PVI date and echocardiograhy findings)

01.01.2026 till 01.01.2027

Investigators with granted permission from PI