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The SENSE-AF study aims to determine the performance of the OptiSense lead in sensing fine episodes of Atrial Tachyarrhythmia/Atrial Fibrillation (AT/AF) and rejecting Far-Field R Wave (FFRW). The performance of the lead will be measured as a difference in device-determined time in AT/AF and surface-ECG determined time in AT/AF. This measurement will be compared to the control group which will be randomized to receive SJM's Tendril™ RA leads.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. Control | Patients will receive the Tendril (wide-spaced) lead as part of their ICD implant |
| |
| 2. Experimental | Patients will receive the OptiSense (narrow-spaced) lead as part of their ICD implant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OptiSense Lead | Device | The OptiSense™ Model 1699 lead is a bipolar, steroid-eluting, silicone-insulated, active fixation implantable lead, designed for long-term pacing and sensing in the right atrium. The tip-to-ring spacing in the OptiSense lead is 1.1mm and "narrow-spaced" compared to the Tendril lead. |
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint of the study is the difference in duration between the device-determined time in AF (Device Duration) and the ECG-determined time in AF (ECG Duration). | 3 months post-implant |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with approved pacemaker indications.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northeast Ohio Cardiovascular Specialists | Akron | Ohio | 44304 | United States | ||
| The Ohio State University |
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| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
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| Tendril Lead | Device | The Tendril® is a bipolar, steroid-eluting, silicone-insulated, active fixation implantable lead, designed for long-term pacing and sensing in either the atrium or the ventricle. The tip-to-ring spacing in the Tendril is "wide spaced" compared to the OptiSense lead. |
|
| Columbus |
| Ohio |
| 43210 |
| United States |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |