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 @ 10:59 PM
Ignite Modification Date:
2025-12-24 @ 10:59 PM
NCT ID:
NCT02611869
Eligibility Criteria:
Inclusion Criteria:
* At least two AF episodes within the last 12 months (either self-terminating within 7 days or cardioverted, medically or electrically, in less than 48 hours),
* AF episodes should have been symptomatic on at least 2 occasions within the last 12 months,
* Failure of at least one class I or III antiarrhythmic to prevent AF paroxysms,
* Age 40-80 years old.
Exclusion Criteria:
* Previous left atrial ablation procedure,
* Left atrial diameter \>50 mm on TTE (parasternal long axis view),
* Known primary electrical heart disease (e.g. Brugada syndrome),
* Presence of atrial thrombus,
* Prosthetic valve at any position,
* Moderate/severe mitral stenosis,
* Severe mitral regurgitation,
* 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),
* Participation in a different research protocol (current or within 1 year),
* Inability or unwillingness to adhere to standard treatment or to provide consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT02611869
Study Brief:
Protocol Section:
NCT02611869