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Sleep breathing tests before and after ablation for atrial fibrillation

Records sleep in adults with paroxysmal atrial fibrillation having a heart ablation.

Key facts

Who runs it
Primula Clinics
Where
Grodzisk Mazowiecki, PolandSee the site
Trial code
Registry title
Impact of Atrial Fibrillation Ablation on Sleep Parameters.
Status
Recruiting
People taking part
100 people, planned
Started
20 Mar 2025
Planned end
28 Feb 2026
Type of study
Observational
Record updated
2 December 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with atrial fibrillation who are scheduled for their first catheter ablation and have at least one risk factor for sleep apnea.

Age
18 years or older
Sex
Men and women can join
Disease stage
Atrial fibrillation (paroxysmal) with catheter ablation (pulmonary vein isolation) scheduled; this must be the first ablation
Earlier treatment
No earlier atrial fibrillation ablation; the study includes only patients having ablation for the first time

Main reasons for not taking part

  • No sleep apnea risk factors
  • Had an atrial fibrillation ablation before

The registry criteria, word for word

Show all 3 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Absence of predefined sleep apnea risk factors

Where in Poland

  • Primula ClinicsGrodzisk Mazowiecki, PolandContact: Paweł Basiukiewicz, MD, PhDTaking people

About the trial

What the trial wants to find out

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

Read full original descriptionShow less

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.

The group in the trial

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

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Assessment of Sleep Parameters Using Polygraphy in Patients With Paroxysmal Atrial Fibrillation Qualified for Pulmonary Vein Isolation - A Prospective Observational Study (AAHI Study)
Plain-language title
Sleep breathing tests before and after ablation for atrial fibrillationGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
2 December 2025