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RESTORE SR II is a feasibility study on the minimally invasive use of the AtriCure Bipolar System for PV Isolation on a beating heart for the treatment of all types of atrial fibrillation in a sole therapy operation (not concomitant to another cardiac operation).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgical Ablation using the AtriCure Bipolar System | Device | Surgical Ablation using the AtriCure Bipolar System |
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome is the feasibility of performing this operation by demonstrating the ability to consistently isolate the right and left PVs using this minimally invasive approach. | Perioperatively | |
| The primary safety endpoint will be determined by assessing the rate of serious adverse events. | Discharge/30 Days |
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Inclusion Criteria:
Male or female patient between 18 and 80 years of age
Patient with symptomatic AF and failure or intolerance of one or more Class I or Class III AADs and:
Left Atrial Size < 6 cm (determined by echocardiography performed within 60 days of enrollment), unless the LV dysfunction is thought to result (at least in part) from AF
Left Ventricular Ejection Fraction ≥ 30% (determined by echocardiography performed within 60 days of enrollment)
Patient is willing and able to provide written informed consent.
Patient has a life expectancy of at least 2 years.
Patient is willing and able to attend the scheduled follow-up visits.
Weight < 325 lbs
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Warren Jackman, MD | University of Oklamhoma Cardiac Arrythmia Research Institute | Principal Investigator |
| James Edgerton, MD | Medical City Hospital/Cardio Pulmonary Research Science and Technology Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Community Hospital/Dr. Kiran C. Patel Research Institute | Tampa | Florida | 33616 | United States | ||
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D013610 | Tachycardia |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| University of Cincinnati |
| Cincinnati |
| Ohio |
| 45267 |
| United States |
| University of Oklahoma Cardiac Arrythmia Research Institute | Oklahoma City | Oklahoma | 73104 | United States |
| Sacred Heart Medical Center Endovascular Research | Eugene | Oregon | 97401 | United States |
| Medical City Hospital/Cardio Pulmonary Research Science and Technology Institute | Dallas | Texas | 75230 | United States |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D000075224 | Cardiac Conduction System Disease |