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 @ 3:52 PM
Ignite Modification Date:
2025-12-24 @ 3:52 PM
NCT ID:
NCT00964392
Eligibility Criteria:
Inclusion Criteria:
Candidates for this registry must meet ALL of the following criteria:
* Patients with drug refractory recurrent symptomatic PAF who have had three (3) AF episodes in the six (6) months prior to enrollment and one AF episode documented within the one (1) year prior to enrollment. Documentation may include electrocardiogram (ECG), transtelephonic monitor (TTM), Holter monitor (HM), or telemetry strip.
* Failure of at least one AAD for AF (class I or III or AV nodal blocking agent such as beta blockers and calcium channel blockers) as evidenced by recurrent symptomatic PAF, or intolerable side effects.
* Age 18 years or older.
* Able and willing to comply with all pre-, post- and follow-up testing and requirements.
* Signed Patient Informed Consent Form.
Exclusion Criteria:
Candidates will be excluded from the registry if any of the following conditions apply:
* Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
* AF episodes that last longer than 30 days and are terminated via cardioversion.
* CABG procedure within the last six (6) months.
* Awaiting cardiac transplantation or other cardiac surgery.
* Documented left atrial thrombus on imaging (i.e., TEE, ICE, CT, or MRA).
* History of a documented thromboembolic event within the past one (1) year.
* Diagnosed atrial myxoma.
* Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this registry.
* Women who are pregnant (by history of menstrual period or pregnancy test if the history is considered unreliable).
* 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 (i.e. heparin or warfarin).
* Life expectancy less than 12 months.
* Enrollment in an investigational 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:
NCT00964392
Study Brief:
Protocol Section:
NCT00964392