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A total of 188 subjects will be enrolled-subjects will be equally (1:1) randomized between those undergoing conventional atrial fibrillation ablation with confirmation of pulmonary vein isolation (PVI) versus those actively treated with the FIRM procedure without PVI.
Enrollment
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Volunteers
Inclusion criteria
Reported incidence of at least two (2) documented episodes of symptomatic paroxysmal atrial fibrillation (AF) during the six months preceding trial entry (at least one episode should be documented by rhythm strip or ECG).
Attempt of at least one Class I or III anti-arrhythmia drug with failure defined as recurrence of symptomatic AF or adverse drug effect resulting in stopping the medication (drug duration and dose will be documented).
Left atrial size <55mm in largest dimension (typically atrial septum to carina of left pulmonary veins) as measured and image documented by preoperative imaging (CT or MRI)
Anticoagulation therapy-Oral anticoagulation required (in the case of Warfarin, therapeutic International Normalized Ratio (INR) for at least three weeks prior to randomization) for those subjects who meet two or more of the following criteria:
Left Ventricular Ejection Fraction ≥ 40% (obtained within 12 months prior to the procedure)
Sustained AF-if the patient is not experiencing spontaneous, sustained AF (>10 min uninterrupted), sustained AF may be induced by burst atrial pacing with or without isoproterenol infusion in conventional clinical fashion.
Exclusion criteria
Previous catheter or surgical left atrial ablation
Structural heart disease of clinical significance including
Congenital heart disease where either the underlying abnormality or its correction prohibits or increases the risk of ablation
Myocardial infarction (MI) within the past three (3) months
Any concomitant arrhythmia or therapy that could interfere with the interpretation of the results from this study
Atrial Septal Defect closure device; Left Atrial Appendage closure device; prosthetic mitral or tricuspid valve
Anaphylactic allergy to contrast media
Atrial fibrillation secondary to electrolyte imbalance
Poor general health that, in the opinion of the investigator, will not allow the patient to be a good study candidate (i.e. other disease processes, mental capacity, etc.)
Reversible cause of atrial fibrillation (e.g. surgery, hyperthyroidism, pericarditis)
Contraindication to heparin and warfarin/other new oral anticoagulants (e.g. dabigatran, rivaroxaban, apixaban [when available])
History of pulmonary embolus within one year of enrollment
Acute pulmonary edema
Atrial clot/thrombus on imaging such as on a trans-esophageal echocardiogram (TEE) performed within 72 hours of the procedure if deemed appropriate by the investigator
Any history of a cerebrovascular disease-including stroke or Transient Ischemic Attack
Any anticipation of cardiac transplantation or other cardiac surgery within the next 365 days (12 months)
History of documented thromboembolic event within the past one year
Diagnosed atrial myxoma
Significant pulmonary disease
Acute illness or active systemic infection or sepsis
Any history of blood clotting abnormalities or bleeding tendencies unrelated to supratherapeutic anticoagulation
Life expectancy <365 days (12 months)
Any intracardiac thrombus, tumor. or other abnormality that precludes safe catheter introduction or manipulation
Continuous AF episode lasting >7 days immediately prior to the procedure without any sinus rhythm
Patients who have previously undergone cardioversion are excluded from participation in the study unless there is documentation that cardioversion has been performed within 72 hours of episode onset
Amiodarone use in the last 6 months
Primary purpose
Allocation
Interventional model
Masking
1 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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