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 @ 6:59 PM
Ignite Modification Date:
2025-12-24 @ 6:59 PM
NCT ID:
NCT00367757
Eligibility Criteria:
Inclusion Criteria:
* Patients age 18 or greater.
* "high burden" of paroxysmal atrial fibrillation or persistent atrial fibrillation
* candidates for AF ablation based on AF that is symptomatic and refractory to at least one antiarrhythmic medication.
* At least one episode of AF must have been documented by ECG or Holter within 12 months of randomization in the trial.
* continuous anticoagulation with warfarin (INR 2-3) for \>4 weeks prior to the ablation.
* Patients must be able and willing to provide written informed consent to participate in the clinical trial.
Exclusion Criteria:
* chronic atrial fibrillation.
* Patients with AF felt to be secondary to an obvious reversible cause.
* inadequate anticoagulation as defined in the inclusion criteria.
* left atrial thrombus or spontaneous echo contrast on TEE prior to procedure.
* contraindications to systemic anticoagulation with heparin or coumadin.
* previously undergone atrial fibrillation ablation.
* left atrial size \> 55 mm.
* Patients who are or may potentially be pregnant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00367757
Study Brief:
Protocol Section:
NCT00367757