Concomitant Treatment of Permanent Atrial Fibrillation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2010-11-30

Brief Summary

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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

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Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No