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 @ 4:16 PM
Ignite Modification Date:
2025-12-24 @ 4:16 PM
NCT ID:
NCT02074566
Eligibility Criteria:
Inclusion Criteria:
* Paroxysmal atrial fibrillation eligible for pulmonary vein isolation according to current international guidelines.
* Age \< 70 years.
* Willing and able to sign informed consent.
* Willing to and capable of following the requested study procedures.
Exclusion Criteria:
* Age \< 18 years.
* Pregnancy
* Life or follow-up expectancy \< 12 months.
* Previous PVI.
* Contrast allergy.
* Creatin clearance level \< 60.
* Left ventricular ejection fraction \< 40%
* Abnormal left atrium anatomy defined as number of PV's ≠ 4 or Left Atrium diameter \>50mm (measured in the parasternal long axis, as assessed with transthoracic echocardiography) or \>40 cc/m2 . This will lead to exclusion after inclusion but before randomisation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02074566
Study Brief:
Protocol Section:
NCT02074566