Impact of Atrial Fibrillation Ablation on Sleep Parameters.
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPrimula Clinics
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial population
Patients with AFib scheduled for pulmonary vein isolation.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
100 Participants
are grouped into 1 trial groupGroup A: Afib scheduled for PVI, at least one risk factor for obstructive sleep apnea.
Trial outcomes
Primary outcomes
1
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.
Time frame
From baseline through study completion, an average of 1 year2
apnea - hypopnea index (AHI) change
Assessment of change of AHI post PVI procedure.
Time frame
From baseline through study completion, an average of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov