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 @ 12:44 PM
Ignite Modification Date:
2025-12-24 @ 12:44 PM
NCT ID:
NCT02113761
Eligibility Criteria:
Inclusion Criteria:
* Male or Female Adults (≥18 years old)
* Minors (15-18 years) of both sexes subject to parental consent or legal representative
* Persistent AF ablation refractory to drugs
* Persistent AF (as defined by consensus statement) for ≤ 12 month duration
* Consent signed by the patient after reading the information leaflet
Exclusion Criteria:
* Any previous left atrial (LA) ablation
* Any previous LA or RA surgery
* Current intra-cardiac thrombus
* Presence of any pulmonary vein stents
* Presence of any pre-existing pulmonary vein stenosis
* Anteroposterior LA diameter \> 5.5 cm by TTE or CT
* Presence of any cardiac valve prosthesis
* Clinically significant mitral valve regurgitation or stenosis
* Myocardial infarction, PCI / PTCA or coronary artery stenting within the last 3 months
* Unstable angina
* Any cardiac surgery within the last 3 months
* NYHA class III or IV congestive heart failure
* Uncontrolled hyperthyroidism
* Any cerebral ischemic event (strokes or TIAs) which occurred during the 6 months interval preceding the consent Date.
* Life expectancy less than one (1) year
* Current or anticipated participation in any other clinical trial of a drug, device or biologic should be done only after prior consultation and approval of the investigator(s)
* Unwilling or unable to comply fully with study procedures and follow-up
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
15 Years
Study:
NCT02113761
Study Brief:
Protocol Section:
NCT02113761