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The purpose of this feasibility study is to assess whether an alternative transvenous lead location affects respiration and airway physiology during a commercial remedē® System or commercial transvenous cardiac device (de novo pacemaker or implantable cardiac defibrillator) implant procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transvenous nerve stimulation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transvenous nerve stimulation | Device | Acute transvenous nerve stimulation during a commercial implant of remedē® System or commercial transvenous cardiac device (de novo pacemaker or implantable cardiac defibrillator). |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in respiration and airway physiology | The primary objective is to assess acute changes in respiration and airway physiology during the respiration cycle during a commercial remedē® System or commercial transvenous cardiac device (de novo pacemaker or implantable cardiac defibrillator) implant. | During procedure (immediately post-stimulation) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathy A McPherson, RN, MSN | Respicardia, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novant Health Forsyth Medical Center | Winston-Salem | North Carolina | 27013 | United States | ||
| The Ohio State University Wexner Medical Center |
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| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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This is an acute, prospective, non-randomized, single arm IDE feasibility study.
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| Columbus |
| Ohio |
| 43210 |
| United States |
| Bryn Mawr Medical Specialists Association | Bryn Mawr | Pennsylvania | 19010 | United States |
| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |