This trial is active, not recruiting.

Condition atrial fibrillation
Treatment surgical ablation using the atricure bipolar system
Phase phase 2
Sponsor AtriCure, Inc.
Start date October 2005
End date December 2007
Trial size 25 participants
Trial identifier NCT00566176, CP2005-1


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).

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

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

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Inclusion Criteria: 1. Male or female patient between 18 and 80 years of age 2. 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. 3. 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 4. Left Ventricular Ejection Fraction ≥ 30% (determined by echocardiography performed within 60 days of enrollment) 5. Patient is willing and able to provide written informed consent. 6. Patient has a life expectancy of at least 2 years. 7. Patient is willing and able to attend the scheduled follow-up visits. 8. Weight < 325 lbs Exclusion Criteria: 1. Prior cardiac catheter ablation for the treatment of arrhythmia within 4 months 2. Prior cardiac surgery 3. Patients requiring any open heart procedure (e.g. CABG, valve replacement or repair, atrial septal defect repair, etc.) 4. Class IV NYHA heart failure symptoms, unless these symptoms are considered to be due to uncontrolled AF 5. Cerebrovascular accident within previous 6 months 6. Known carotid artery stenosis greater than 80% 7. Evidence of significant active infection 8. Patient unable to undergo TEE 9. Pregnant woman 10. Requires anti-arrhythmic drug therapy for the treatment of ventricular arrhythmia 11. Presence of thrombus in the left atrium 12. Patient has co-morbid condition that in the opinion of the investigator poses undue risk of general anesthesia or port access cardiac surgery 13. Patient is enrolled in another investigational study

Additional Information

Official title Thoracoscopically-Assisted Epicardial Bilateral Pulmonary Vein Isolations Using the AtriCure Bipolar System and Exclusion of the Left Atrial Appendage for the Treatment of Atrial Fibrillation
Principal investigator Warren Jackman, MD
Trial information was received from ClinicalTrials.gov and was last updated in February 2013.
Information provided to ClinicalTrials.gov by AtriCure, Inc..