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The purpose of this study is to test the safety and efficacy of the Epicor LP Cardiac Ablation System for treating permanent atrial fibrillation during concomitant open chest and/or open heart surgery for one of more of the following procedures: mitral valve repair or replacement, aortic valve repair or replacement, tricuspid valve repair or replacement, coronary artery bypass surgery or patent foramen ovale (PFO closure).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epicor Cardiac Ablation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epicor LP Cardiac Ablation System | Device | Surgical ablation of permanent AF during concomitant open chest and/or open heart surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Freedom From Atrial Fibrillation in the Absence of Any AF Therapies | Freedom from atrial fibrillation (AF) at 6 months in absence of any AF therapies. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Groh, MD | Mission Hospitals | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Agnes Medical Center | Fresno | California | 93720 | United States | ||
| Manatee Memorial Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Epicor Cardiac Ablation | Epicor LP Cardiac Ablation System: Surgical ablation of permanent AF during concomitant open chest and/or open heart surgery Surgical ablation of permanent AF: Concomitant AF ablation during mitral,aortic, and or tricuspid valve surgery, PFO closure or CABG procedure |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Surgical ablation of permanent AF | Procedure | Concomitant AF ablation during mitral valve surgery |
|
| Bradenton |
| Florida |
| 34208 |
| United States |
| Blake Medical Center | Bradenton | Florida | 34209 | United States |
| Cardiology Consultants, MD's PA (Baptist Hospital) | Pensacola | Florida | 32501 | United States |
| NorthShore University Health System | Evanston | Illinois | 60201 | United States |
| Community Hospital | Munster | Indiana | 46321 | United States |
| Midatlanatic Cardiovascular Associates, PA; Union Memorial Hospital | Baltimore | Maryland | 21218 | United States |
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | United States |
| Minneapolis Heart Institute Foundation/Abbott NW Hospital | Minneapolis | Minnesota | 55407 | United States |
| HealthEast St. Joseph's Hospital | Saint Paul | Minnesota | 55102 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| St. Francis Hospital | Roslyn | New York | 11576 | United States |
| Mission Hospital, Inc | Asheville | North Carolina | 28801 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| COMPLETED |
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| NOT COMPLETED |
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Subjects treated
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| ID | Title | Description |
|---|---|---|
| BG000 | Epicor Cardiac Ablation | Epicor LP Cardiac Ablation System: Surgical ablation of permanent AF during concomitant open chest and/or open heart surgery Surgical ablation of permanent AF: Concomitant AF ablation during mitral valve surgery |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Freedom From Atrial Fibrillation in the Absence of Any AF Therapies | Freedom from atrial fibrillation (AF) at 6 months in absence of any AF therapies. | Posted | Number | participants | 6 months |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Epicor Cardiac Ablation | Epicor LP Cardiac Ablation System: Surgical ablation of permanent AF during concomitant open chest and/or open heart surgery Surgical ablation of permanent AF: Concomitant AF ablation during mitral valve surgery | 11 | 112 | 1 | 112 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac injury related to Epicor device rsulting in unplanned surgical or catheter intervention | Cardiac disorders | Systematic Assessment |
| ||
| Death | Cardiac disorders | Systematic Assessment |
| ||
| Myocardial infarction | Cardiac disorders | Systematic Assessment |
| ||
| Newly developed third degree AV block requiring permanent pacemaker implantation | Cardiac disorders | Systematic Assessment |
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| Peripheral arterial embolism | Vascular disorders | Systematic Assessment |
| ||
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute heart failure | Cardiac disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sue Walgren, Manager Sr., Clinical Project | St. Jude Medical | 6517563210 | swalgren@sjm.com |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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