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The Evia HF-T and the Entovis HF-T are triple-chamber pacemakers for cardiac resynchronisation therapy (CRT-P). The objective of this study is to prove the safety and efficacy of these pacemakers. In particular, the left ventricular (LV) capture control feature is evaluated, which automatically measures the LV pacing threshold and subsequently adjusts the pacing output.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CRT pacemaker implantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evia/Entovis HF-T pacemaker for CRT therapy | Device | Implantation of CRT pacemaker and standard follow-ups at pre-hospital discharge, and after 1, 3 and 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Serious Adverse Device Effect (SADE) free rate | While the investigator is asked to record all adverse events throughout the study, only the number of SADEs possibly or securely related to a device deficiency will be the basis for the calculation of the SADE free rate: (1-number of SADE divided by number of patients)%. | Until 3 month follow-up |
| Efficacy of the left ventricular capture control feature (focus on threshold measurements) | Absolute difference between the triggered automatic and manual pacing threshold in the left ventricle is smaller than 0.3 Volt. | At pre-hospital discharge, 1 and 3 month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of the left ventricular capture control feature (focus on pulse amplitude adjustment) | Rate of appropriate adjustment of the left ventricular (LV) pulse amplitude by the LV capture control feature is greater than 90%. | 1 and 3 month follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with indication for CRT therapy
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Semmelweis University | Budapest | 1122 | Hungary |
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