Concomitant Treatment of Permanent Atrial Fibrillation (RESTORE SR)

AtriCure

Status and phase: Completed; Phase 3

Conditions: Atrial Fibrillation

Treatments: Device: Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System

Study type: Interventional

Funder types: Industry

Identifiers

NCT00566787

CP2003-1

Details and patient eligibility

About

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

Enrollment: 39 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)