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:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-25 @ 4:04 AM
NCT ID:
NCT02150902
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥18 years
2. Subjects must have symptomatic Paroxysmal AF that is refractory to at least one class I or Class III antiarrhythmic medication OR be intolerant of antiarrhythmic medications OR prefer not to trial antiarrhythmic medications
3. At least one episode of AF documented on 12-lead ECG, Holter monitor or Loop recorder.
4. Subjects must be able to provide informed consent
Exclusion Criteria:
1. Subjects with persistent or permanent AF
2. History of previous catheter or surgical ablation for AF
3. Presence of known intracardiac thrombus
4. Subjects with contraindication to systemic oral anticoagulation therapy, including a history of Heparin Induced Thrombocytopenia
5. Subjects with reversible causes of AF
6. Subjects with significant valve disease (moderate or severe mitral/aortic stenosis or regurgitation)
7. Subjects with known adverse reaction to adenosine
8. Subjects with congenital heart disease
9. Subjects that are pregnant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02150902
Study Brief:
Protocol Section:
NCT02150902