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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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System | Device | Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System |
| 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 |
| 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) |
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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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| A. Marc Gillinov, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heart Center of Indiana | Indianapolis | Indiana | 46290 | United States | ||
| University of Michigan |
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| Discharge |
| Ann Arbor |
| Michigan |
| 48109 |
| United States |
| Spectrum Health | Grand Rapids | Michigan | 49506 | United States |
| Mayo Clinic | Rochester | Minnesota | 55902 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| The Methodist Hospital | Houston | Texas | 77030 | United States |
| Sentara Norfolk Hospital | Norfolk | Virginia | 23507 | United States |
| Sacred Heart Medical Center | Seattle | Washington | 99220 | United States |
| St. Mary's Hospital Medical Center | Madison | Wisconsin | 53715 | United States |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D013610 | Tachycardia |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000075224 | Cardiac Conduction System Disease |
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