NAVISTAR® THERMOCOOL® SF Catheter: Observational Study (NCT01585961) | Clinical Trial Compass
CompletedNot Applicable
NAVISTAR® THERMOCOOL® SF Catheter: Observational Study
United States511 participantsStarted 2012-04
Plain-language summary
This is a prospective, interventional, observational, unblinded, single-arm, multicenter registry of younger and older subjects with drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation
* Age 18 years or older
* Patients must be able and willing to provide written informed consent to participate in the study
Exclusion Criteria:
* Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
* Previous ablation for atrial fibrillation
* Episodes of atrial fibrillation that last longer than 30 days and are terminated via cardioversion
* Uncontrolled heart failure, or NYHA Class III or IV heart failure
* Documented intra-atrial thrombus or other abnormality on pre-ablation echocardiogram
* Contraindication to anticoagulation
* Stroke, cardiac surgery, unstable angina, myocardial infarction or percutaneous coronary intervention within the past 3 months
* Awaiting cardiac transplantation
* Heart disease in which corrective surgery is anticipated within 6 months
* Enrollment in investigational drug, biologic or device study
* Subjects unwilling to comply with protocol or follow-up requirements
* Patients who are pregnant