Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2025-12-24 @ 3:57 PM
NCT ID:
NCT02727192
Eligibility Criteria:
Inclusion Criteria:
* Age 18-75 years
* Male or female
* Patients with paroxysmal AF scheduled for first or second catheter ablation
* Moderate-to-severe SA defined as an AHI ≥15/h (OSA and/or CSA)
* Signed informed consent
Exclusion Criteria:
* Unstable patients
* Patients with left ventricular ejection fraction (LV-EF) \< 45%
* Unstable coronary artery disease, myocardial infarction or PCI within 3 months prior to the study
* Bypass surgery within 6 months prior to the study
* Patients with TIA or stroke within the previous 3 months
* BMI \> 40kg/m2
* Drowsy drivers and/or sleepy patients with ESS (Epworth Sleepiness Score) \> 15
* Patients with interstitial lung diseases, severe obstructive lung defects, and thoracic myopathies or severe obstructive lung defects with FEV1 \< 50% of predicted
* Oxygen saturation \< 90% at rest during the day
* Poor compliance
* Patients with single chamber pacemaker (or ICD)
* Current use of PAP therapy
* Patients using amiodarone
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02727192
Study Brief:
Protocol Section:
NCT02727192