NAVISTAR® THERMOCOOL® Catheter Post Approval Registry
437 participantsStarted 2009-09-01
Plain-language summary
The purpose of this registry is to provide additional corroborative short-term safety and long-term safety data for the NAVISTAR THERMOCOOL and NAVISTAR EZ STEER THERMOCOOL catheters in the treatment of symptomatic Paroxysmal Atrial Fibrillation (PAF).
Who can participate
Age range18 Years
SexALL
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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 th…
What they're measuring
1
The Percentage of Subjects Experiencing Primary Adverse Events Within Seven Days of the Ablation Procedure.