Phase
Condition
Chest Pain
Dysrhythmia
Arrhythmia
Treatment
N/AClinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patient between 18 and 80 years of age
Patient with documented symptomatic persistent or permanent AF and failure orintolerance of one or more Class I or Class III antiarrhythmic drugs.
Persistent AF: AF that is not self-terminating or is terminated electrically orpharmacologically.
Longstanding AF: Persistent AF of 12 months (or longer) duration.
Permanent AF: Longstanding AF in which electrical or pharmacologicalcardioversion has failed or has not been attempted.
Patient is willing and able to provide written informed consent.
Patient has a life expectancy of at least 2 years.
Patient is willing and able to attend the scheduled follow-up visits.
Exclusion
Exclusion Criteria:
Prior cardiac catheter ablation for the treatment of arrhythmia within 4 months.
Patients who refuse, but have not failed and can tolerate anti-arrhythmic medications
Myocardial infarction within 8 weeks.
Prior cardiac surgery.
Patient requires cardiac surgery for treatment other than for AF.
Class IV NYHA heart failure symptoms, unless due to uncontrolled AF
Cerebrovascular accident within previous 6 months
Known carotid artery stenosis greater than 80%
Evidence of significant active infection
Patient unable to undergo TEE
Pregnant woman
Patient requires anti-arrhythmic drug therapy for the treatment of ventriculararrhythmia
Presence of thrombus in the left atrium
Co-morbid condition that in the opinion of the investigator poses undue risk ofgeneral anesthesia or port access cardiac surgery
Patient is enrolled in another cardiac clinical trial
Left ventricular ejection fraction < 30%
Left atrial transverse diameter >6.0
Patient has undergone previous thoracic targeted radiation