Impact of Atrial Fibrillation Ablation on Sleep Parameters.

NCT07259200 | Recruiting

• 1 other identifier: KB/1641/25
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atrial Fibrillation (AF); OSA - Obstructive Sleep Apnea; Pulmonary Vein Isolation

Keywords

atrial fibrillation; sleep apnea; sleep apnoea; ablation; pulmonary vein isolation; pvi; snoring; choking; somnolence

Outcome Measures

Primary Outcomes (2)

• Change from the baseline in post ablation apnea-hypopnea index (AHI)

  Change in apnea - hypopnea index after atrial fibrillation ablation (pulmonary vein isolation). Improvement will be assessed as a decrease in the Apnea-Hypopnea Index.

  From baseline through study completion, an average of 1 year

• apnea - hypopnea index (AHI) change

  Assessment of change of AHI post PVI procedure.

  From baseline through study completion, an average of 1 year

Study Arms (1)

Afib scheduled for PVI, at least one risk factor for obstructive sleep apnea.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with AFib scheduled for pulmonary vein isolation.

You may qualify if:

• 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.

You may not qualify if:

• \- Absence of predefined sleep apnea risk factors.

Sponsors & Collaborators

• Primula Clinics: lead

Study Sites (1)

Primula Clinics

Grodzisk Mazowiecki, 05-825, Poland

RECRUITING

Related Publications (3)

• Shantha G, Pelosi F, Morady F. Relationship Between Obstructive Sleep Apnoea and AF. Arrhythm Electrophysiol Rev. 2019 Jul;8(3):180-183. doi: 10.15420/aer.2019.35.2.

  PMID: 31463055 BACKGROUND

• Linz D, Baumert M, Desteghe L, Kadhim K, Vernooy K, Kalman JM, Dobrev D, Arzt M, Sastry M, Crijns HJGM, Schotten U, Cowie MR, McEvoy RD, Heidbuchel H, Hendriks J, Sanders P, Lau DH. Nightly sleep apnea severity in patients with atrial fibrillation: Potential applications of long-term sleep apnea monitoring. Int J Cardiol Heart Vasc. 2019 Oct 18;24:100424. doi: 10.1016/j.ijcha.2019.100424. eCollection 2019 Sep.

  PMID: 31763438 BACKGROUND

• Van Gelder IC, Rienstra M, Bunting KV, Casado-Arroyo R, Caso V, Crijns HJGM, De Potter TJR, Dwight J, Guasti L, Hanke T, Jaarsma T, Lettino M, Lochen ML, Lumbers RT, Maesen B, Molgaard I, Rosano GMC, Sanders P, Schnabel RB, Suwalski P, Svennberg E, Tamargo J, Tica O, Traykov V, Tzeis S, Kotecha D; ESC Scientific Document Group. 2024 ESC Guidelines for the management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2024 Sep 29;45(36):3314-3414. doi: 10.1093/eurheartj/ehae176. No abstract available.

  PMID: 39210723 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation; Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Snoring; Airway Obstruction; Sleepiness

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Respiratory Sounds; Signs and Symptoms, Respiratory; Signs and Symptoms; Respiratory Insufficiency

Study Officials

• Paweł S Basiukiewicz, MD, PhD

  Primula Clinics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paweł S Basiukiewicz, MD, PhD

CONTACT

+48 698612826; pbasiukiewicz@gmail.com

Piotr Futyma, MD, PhD

CONTACT

+48 533503044; piotr.futyma@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: December 2, 2025
• Study Start: March 20, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 28, 2026
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 01.01.2026 till 01.01.2027
• Access Criteria: Investigators with granted permission from PI

Locations

PL (1)