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This study will collect data, from an implanted Cardiac Resynchronization Therapy-Defibrillator (CRT-D) device, to further evaluate a new feature for future heart failure devices.
ELEVATE 2.0 is an acute, prospective, multi-center, feasibility study randomized within patient test sequence and pulse width, designed to characterize the performance of the Left Ventricular Auto Threshold (LVAT) feature.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Two experimental and/or intervention groups under 1 arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CRT-D | Device | Cardiac pacing via a pulse generator and implanted intracardiac leads |
|
| Measure | Description | Time Frame |
|---|---|---|
| Collect ventricular evoked response signals and CRT-D device data during LV only and Bi-ventricular (Bi-V) voltage step down pacing | The primary objective of this study is to collect real-time signals during LV pacing voltage step-down from patients with implanted COGNIS CRT-D devices in a follow-up setting. This data will be used to assess the stability of the LV evoked response electrogram signal and will be used in an offline assessment of the LVAT algorithm. One or two data points will be collected per patient in the trial. Patients must be at least 24 hours post implant of their COGNIS CRT-D device | At least 24 hours post CRT-D implant |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will be a sample of patients with COGNIS CRT-D devices and bipolar LV leads.
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth L Ellenbogen, M.D. | Virginia Commonwealth University Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regional Cardiovascular Medical Center | Stuebenville | Ohio | 43952 | United States |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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