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 @ 11:14 PM
Ignite Modification Date:
2025-12-24 @ 11:14 PM
NCT ID:
NCT03573869
Eligibility Criteria:
Inclusion criteria:
* A minimum of at least two separate AF episodes recorded within the last 12 months, either on 12-lead rest ECG or on ambulatory ECG recordings (at least 5 minutes of AF on Holter recordings will be required),
* LVEF \<40% on sinus rhythm,
* symptoms consistent with heart failure (New York Heart Association II or higher) despite rate control treatment,
* age \>21 years old.
Exclusion criteria:
* previous left atrial ablation,
* left atrial diameter \>28 mm/m2 BSA on TTE (parasternal long axis view),
* strong clinical suspicion that reduced LVEF is primarily due to tachycardiomyopathy,
* pre-existing device (ICD or CRT) without AF detection algorithms and/or (for CRT devices) diagnostics of effective biventricular pacing,
* known primary electrical heart disease (e.g. Brugada syndrome),
* presence of thrombus in a heart chamber,
* presence of prosthetic valve at any position,
* moderate/severe valvular heart disease,
* active infectious disease or malignancy,
* moderate or severe hepatic impairment (Child-Pugh class B or C),
* severe renal failure (estimated glomerular filtration rate \<20 ml/min/1.73 m2),
* inability or unwillingness to adhere to standard treatment or to provide consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT03573869
Study Brief:
Protocol Section:
NCT03573869