Master Study of the Evia/Entovis HF-T Pacemaker
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Indication for Cardiac Resynchronization Therapy (CRT)
- Sponsor
- Biotronik SE & Co. KG
- Enrollment
- 122
- Locations
- 1
- Primary Endpoint
- Safety: Serious Adverse Device Effect (SADE) free rate
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Standard indication for CRT therapy
- •Legal capacity and ability to consent
- •Signed patient informed consent
Exclusion Criteria
- •Contraindication for CRT therapy
- •ICD indication
- •Age \< 18 years
- •Pregnant or breast-feeding woman
- •Cardiac surgery planned within the next 6 months
- •Life expectancy of less than 6 months
- •Participating in another clinical study of an investigational cardiac drug or device
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Efficacy of the left ventricular capture control feature (focus on pulse amplitude adjustment)(1 and 3 month follow-up)