Evia/Entovis HF-T Master Study
|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|
|Primary Completion Date :||December 2013|
|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%.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01545739
|Budapest, Hungary, 1122|