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Investigation of the efficacy and safety of the Ventricular Pace Suppression (VpS) algorithm.
The aim of this study is to investigate the percentage of reduction of ventricular pacing using the VpS feature of the EVIA/ENTOVIS pacemaker in a controlled clinical investigation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ventricular Pace Suppression- ON | Other |
| |
| Ventricular Pace Suppression- OFF | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VpS algorithm in EVIA and ENTOVIS pacemakers | Device | For one group of patients, the VpS algorithm will be activated and for the other group, the VpS algorithm will be deactivated until the cross-over, where these conditions will be switched. |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of right ventricular pacing with the help of the VpS algorithm in the EVIA/ ENTOVIS pacemakers. | 6-8 months |
| Measure | Description | Time Frame |
|---|---|---|
| A Complication free rate >95%, with respect to the VpS feature of the implanted pacemaker. | 6-8 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hendrik Bonnemeier, Prof. Dr. | Klinik für Kardiologie und Angiologie, UNIVERSITÄTSKLINIKUM Schleswig-Holstein, Campus Kiel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Coburg gGmbH | Coburg | Bavaria | 96450 | Germany | ||
| Abteilung für Elektrophysiologie, Klinik für Kardiologie und Angiologie, UNIVERSITÄTSKLINIKUM Schleswig-Holstein |
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| Kiel |
| Schleswig-Holstein |
| 24105 |
| Germany |