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:
2025-12-26 @ 10:16 PM
Ignite Modification Date:
2025-12-26 @ 10:16 PM
NCT ID:
NCT01562912
Eligibility Criteria:
Inclusion Criteria:
* Patients aged 18 years or greater.
* Patients undergoing first-time catheter ablation for AF.
* Patients with paroxysmal AF. Paroxysmal AF will be defined as self-terminating episodes less than 7 days duration. Patients should have had at least 3 episodes of AF in a one year period.
* Patients with symptomatic AF that is refractory to at least one antiarrhythmic medication. "Symptomatic" patients are those who have been aware of their AF anytime within the last 5 years prior to enrollment. Symptoms may include, but are not restricted to, palpitations, shortness of breath, chest pain, fatigue, or any combination of the above.
* At least one episode of AF must have been documented by ECG, Holter, loop recorder, telemetry, or transtelephonic monitoring within 24 months of enrollment in the study.
* Patients must be able and willing to provide written informed consent to participate in the clinical study.
Exclusion Criteria:
* Patients with persistent AF (defined as an episode of AF lasting \>7 days).
* Patients with AF felt to be secondary to an obvious reversible cause.
* Patients with contraindications to systemic anticoagulation with heparin or warfarin or a direct thrombin inhibitor.
* Patients who have previously undergone AF ablation.
* Patients with left atrial size \>/= 55 mm (2D echocardiography, parasternal long axis view).
* Patients who are or may potentially be pregnant.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01562912
Study Brief:
Protocol Section:
NCT01562912