Atrial Fibrillation
Conditions
Keywords
Atrial Fibrillation, AF, AFIB, racing heart, pulmonary vein isolation, pvi, mini maze, maze
Brief summary
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).
Interventions
DEVICESurgical Ablation using the AtriCure Bipolar System
Surgical Ablation using the AtriCure Bipolar System
Sponsors
AtriCure, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | Perioperatively |
| The primary safety endpoint will be determined by assessing the rate of serious adverse events. | Discharge/30 Days |
Countries
United States
Outcome results
None listed