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 @ 6:48 PM
Ignite Modification Date:
2025-12-24 @ 6:48 PM
NCT ID:
NCT01116557
Eligibility Criteria:
Inclusion Criteria:
* Patients with PAF who have had two (2) symptomatic PAF episodes in the six (6) months prior to randomization, and who are selected for catheter ablation for the treatment of their AF. Additionally patients with recurrent AF with episodes up to 30 days with sinus rhythm maintained for more than one week following cardioversion and who require PVI only for the treatment of their AF (supported by the consensus statement2). At least one AF episode should be documented either on ECG, TTM, HM or telemetry strip.
* Failure of at least one AAD for PAF \[class I or III\] as evidenced by recurrent symptomatic PAF, or intolerable side effects due to the AAD.
* Signed Patient Informed Consent Form.
* Age 18 years or older.
* Able and willing to comply with all pre- and follow-up testing and requirements.
Exclusion Criteria:
* Longstanding persistent atrial fibrillation
* Patients with a history of any atrial flutter requiring ablation in the right atrium during the study procedure
* Patients in whom sinus rhythm was maintained for less than 1 week after electrical cardioversion
* Previous ablation for AF
* LA size \> 55 mm
* LVEF \< 40% (ejection fraction)
* AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
* CABG procedure within the last six (6) months
* Awaiting cardiac transplantation or other cardiac surgery
* Documented left atrial thrombus on imaging (eg, TEE)
* Diagnosed atrial myxoma
* Women who are pregnant (by history of menstrual period or pregnancy test if the history is considered unreliable) or breastfeeding
* Acute illness or active systemic infection or sepsis
* Unstable angina
* Uncontrolled heart failure
* Myocardial infarction within the previous two (2) months
* History of blood clotting or bleeding abnormalities
* Contraindication to anticoagulation therapy (ie. heparin or warfarin)
* Life expectancy less than 12 months
* Enrollment in any other study evaluating another device or drug
* Presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction or manipulation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01116557
Study Brief:
Protocol Section:
NCT01116557