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| Name | Class |
|---|---|
| Northwestern University | OTHER |
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While surgical treatment for atrial fibrillation (AF) has been performed for over 20 years, virtually all of the historical series reported only the recurrence of symptomatic AF and have used only intermittent electrocardiogram (ECG) follow-up. This study compares the use of traditional arrhythmia assessment (ECG and 24-hour holter monitoring) with the use of the Medtronic Reveal XT device to continuously record heart rhythm to quantify postoperative arrhythmia burden following surgical treatment for AF in patients undergoing either lone or concomitant heart surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reveal XT | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reveal XT implantation | Device | The implantation of the Reveal XT device will be performed at the time of surgery before the planned median sternotomy or thoracotomy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of ATA (Atrial Tachyarrhythmias) Episodes and Burden, Determined at Defined Postoperative Intervals | ILR monitoring obtained at 3, 6 and 12 months | |
| Freedom From Atrial Tachyarrhythmias (ATAs) | ILR monitoring at 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ralph J Damiano, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States | ||
| Washington University School of Medicine |
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A total of 47 consecutive patients who received an implantable loop recorder (ILR) after a surgical ablation procedure were followed between August 2011 and January 2014. Patients with AF who were scheduled to undergo elective surgical ablation procedure that included a CM IV lesion set or pulmonary vein isolation were eligible.
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| ID | Title | Description |
|---|---|---|
| FG000 | Reveal XT | Reveal XT implantation: The implantation of the Reveal XT device will be performed at the time of surgery before the planned median sternotomy or thoracotomy. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Reveal XT | Reveal XT implantation: The implantation of the Reveal XT device will be performed at the time of surgery before the planned median sternotomy or thoracotomy. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of ATA (Atrial Tachyarrhythmias) Episodes and Burden, Determined at Defined Postoperative Intervals | Posted | Number | ATA episodes | ILR monitoring obtained at 3, 6 and 12 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 | Reveal XT | Reveal XT implantation: The implantation of the Reveal XT device will be performed at the time of surgery before the planned median sternotomy or thoracotomy. No reportable adverse events occurred. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Bell, Manager of Clinical Trials | Washington University School of Medicine | 314-747-6969 | jennifer.bell@wustl.edu |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| St Louis |
| Missouri |
| 63110 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Freedom From Atrial Tachyarrhythmias (ATAs) | Participants with available data at 1 year and who were compliant with use of each device. | Posted | Number | Participants | ILR monitoring at 12 months |
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| 0 |
| 47 |
| 0 |
| 47 |
| 0 |
| 47 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
|
| Freedom from ATAs at 1 year, ECG |
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