Concomitant Treatment of Permanent Atrial Fibrillation

Study Overview
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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

Official Title
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A Prospective, Multi-center Study With Case Matched Controls to Evaluate the Safety and Efficacy of the AtriCure Bipolar System for the Treatment of Continuous Atrial Fibrillation as Adjunct Therapy to Elective Open Heart Surgery

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or Female subject between 18 to 80 years of age 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) Left Ventricular Ejection Fraction ≥ 30% Subject is willing and able to provide written informed consent Subject has a life expectancy of at least 2 years Subject is willing and able to return for scheduled follow-up visits TREATMENT SUBJECTS ONLY: Subject has a 3 month documented history of continuous atrial fibrillation CONTROL SUBJECTS ONLY: Subject is not in atrial fibrillation at time of surgery Exclusion Criteria: Lone AF without indication(s) for concomitant CABG and/or mitral valve surgery, aortic valve surgery, tricuspid valve surgery or double valve surgery Prior cardiac surgery (Redo -including previous ablation) 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 Serum creatinine concentration greater than 2.0 mg/dl Class IV NYHA heart failure symptoms and/or Class IV CCS anginal symptoms Prior history of cerebrovascular accident within 6 months or at any time if there is residual neurologic deficit Active infection Known carotid artery stenosis greater than 80% Severe peripheral arterial occlusive disease defined as claudication with minimal exertion A known drug and/or alcohol addiction Mental impairment or other conditions which may not allow the the subject to understand the nature, significance and scope of the study Pregnancy or desire to get pregnant within 12 months of study enrollment Requires anti-arrhythmic drug therapy for the treatment of a ventricular arrhythmia

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System|Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AF, cabg, Atrial Fibrillation, afib, racing heart, valve, ablation, bipolar, radiofrequency, rf