Sole-Therapy Treatment of Atrial Fibrillation (RESTORE SR II)
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ClinicalTrials.gov Identifier: NCT00566176
Recruitment Status : Unknown
Verified February 2013 by AtriCure, Inc.. Recruitment status was: Active, not recruiting
RESTORE SR II is a feasibility study on the minimally invasive use of the AtriCure Bipolar System for PV Isolation on a beating heart for the treatment of all types of atrial fibrillation in a sole therapy operation (not concomitant to another cardiac operation).
Condition or disease
Device: Surgical Ablation using the AtriCure Bipolar System
The primary outcome is the feasibility of performing this operation by demonstrating the ability to consistently isolate the right and left PVs using this minimally invasive approach. [ Time Frame: Perioperatively ]
The primary safety endpoint will be determined by assessing the rate of serious adverse events. [ Time Frame: Discharge/30 Days ]
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Ages Eligible for Study:
18 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Male or female patient between 18 and 80 years of age
Patient with symptomatic AF and failure or intolerance of one or more Class I or Class III AADs and:
Who describes 3 or more symptomatic AF episodes during the 6 month period prior to enrollment, with at least 1 electrocardiographically documented episode of AF in the 4 months prior to enrollment or,
Who has documented AF within the 6 months proceeding enrollment that did not terminate spontaneously (including patients in continuous AF) or,
Who is unwilling or unable to take anticoagulants, with 3 or more symptomatic episodes during the 6 month period prior to enrollment with at least 1 electrocardiographically documented episode of AF in the 4 months prior to enrollment.
Left Atrial Size < 6 cm (determined by echocardiography performed within 60 days of enrollment), unless the LV dysfunction is thought to result (at least in part) from AF
Left Ventricular Ejection Fraction ≥ 30% (determined by echocardiography performed within 60 days of enrollment)
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.
Weight < 325 lbs
Prior cardiac catheter ablation for the treatment of arrhythmia within 4 months
Prior cardiac surgery
Patients requiring any open heart procedure (e.g. CABG, valve replacement or repair, atrial septal defect repair, etc.)
Class IV NYHA heart failure symptoms, unless these symptoms are considered to be 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
Requires anti-arrhythmic drug therapy for the treatment of ventricular arrhythmia
Presence of thrombus in the left atrium
Patient has co-morbid condition that in the opinion of the investigator poses undue risk of general anesthesia or port access cardiac surgery
Patient is enrolled in another investigational study