Evia/Entovis HF-T Master Study
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|ClinicalTrials.gov Identifier: NCT01545739|
Recruitment Status : Completed
First Posted : March 7, 2012
Last Update Posted : October 16, 2014
|Condition or disease||Intervention/treatment|
|Indication for Cardiac Resynchronization Therapy (CRT)||Device: Evia/Entovis HF-T pacemaker for CRT therapy|
|Study Type :||Observational|
|Actual Enrollment :||122 participants|
|Official Title:||Master Study of the Evia/Entovis HF-T Pacemaker|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
|CRT pacemaker implantation||
Device: Evia/Entovis HF-T pacemaker for CRT therapy
Implantation of CRT pacemaker and standard follow-ups at pre-hospital discharge, and after 1, 3 and 6 months
- Safety: Serious Adverse Device Effect (SADE) free rate [ Time Frame: Until 3 month follow-up ]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)%.
- Efficacy of the left ventricular capture control feature (focus on threshold measurements) [ Time Frame: At pre-hospital discharge, 1 and 3 month follow-up ]Absolute difference between the triggered automatic and manual pacing threshold in the left ventricle is smaller than 0.3 Volt.
- Efficacy of the left ventricular capture control feature (focus on pulse amplitude adjustment) [ Time Frame: 1 and 3 month follow-up ]Rate of appropriate adjustment of the left ventricular (LV) pulse amplitude by the LV capture control feature is greater than 90%.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01545739
|Budapest, Hungary, 1122|