Atrial Fibrillation
Conditions
Keywords
AF, Atrial Fibrillation, afib, racing heart, cabg, valve, ablation, bipolar, radiofrequency, rf
Brief summary
RESTORE-SR study is a multi-center, prospective, nonrandomized study with case matched concurrent controls to evaluate the safety and efficacy of the AtriCure Bipolar System
Interventions
DEVICESurgical bipolar radiofrequency ablation using the AtriCure Bipolar System
Surgical bipolar radiofrequency 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 subject between 18 to 80 years of age 2. Subject is scheduled to undergo elective cardiac surgical procedure(s) to be performed on cardiopulmonary bypass including: * coronary artery bypass and/or * mitral valve surgery (repair or replacement) * aortic valve surgery (repair or replacement) * tricuspid valve surgery (repair or replacement) 3. Left Ventricular Ejection Fraction ≥ 30% 4. Subject is willing and able to provide written informed consent 5. Subject has a life expectancy of at least 2 years 6. Subject is willing and able to return for scheduled follow-up visits 7. TREATMENT SUBJECTS ONLY: Subject has a 3 month documented history of continuous atrial fibrillation 8. CONTROL SUBJECTS ONLY: Subject is not in atrial fibrillation at time of surgery
Exclusion criteria
1. Lone AF without indication(s) for concomitant CABG and/or mitral valve surgery, aortic valve surgery, tricuspid valve surgery or double valve surgery 2. Prior cardiac surgery (Redo -including previous ablation) 3. Patient requires atrial septal defect repair or any other concomitant open-heart procedure, other than CABG and/or mitral valve surgery; aortic valve surgery, tricuspid valve surgery or double valve surgery 4. Serum creatinine concentration greater than 2.0 mg/dl 5. Class IV NYHA heart failure symptoms and/or Class IV CCS anginal symptoms 6. Prior history of cerebrovascular accident within 6 months or at any time if there is residual neurologic deficit 7. Active infection 8. Known carotid artery stenosis greater than 80% 9. Severe peripheral arterial occlusive disease defined as claudication with minimal exertion 10. A known drug and/or alcohol addiction 11. Mental impairment or other conditions which may not allow the the subject to understand the nature, significance and scope of the study 12. Pregnancy or desire to get pregnant within 12 months of study enrollment 13. Requires anti-arrhythmic drug therapy for the treatment of a ventricular arrhythmia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary efficacy endpoint is the proportion of treated patients who are free of atrial fibrillation without the need for anti-arrhythmic agents at the six-month follow-up visit. | 6 months |
| The primary safety endpoint is the occurrence of serious adverse events that are considered to be associated with the Maze procedure. | 30 days |
Secondary
| Measure | Time frame |
|---|---|
| The secondary efficacy endpoint is the proportion of patients in the treatment group who are free of atrial fibrillation independent of the need for anti-arrhythmic drugs. | 6 Months |
| The secondary safety endpoints are: total cross clamp time, total time on bypass, length of hospital stay (days), and length of ICU stay (hours) | Discharge |
Countries
United States
Outcome results
None listed