Evia/Entovis HF-T Master Study

Completed

• Conditions: Indication for Cardiac Resynchronization Therapy (CRT)
• Interventions: Device: Evia/Entovis HF-T pacemaker for CRT therapy

• Registration Number: NCT01545739
• Lead Sponsor: Biotronik SE & Co. KG

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-03-01
• Study First Submitted QC: 2012-03-06
• Study First Posted: 2012-03-07
• Study Start: 2012-04
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-15
• Last Update Posted: 2014-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CRT pacemaker implantation	Evia/Entovis HF-T pacemaker for CRT therapy	-

Primary Outcome Measures

Name	Time	Method
Safety: Serious Adverse Device Effect (SADE) free rate	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)	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 Outcome Measures

Name	Time	Method
Efficacy of the left ventricular capture control feature (focus on pulse amplitude adjustment)	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%.

Trial Locations

Locations (1)

Semmelweis University; 🇭🇺 Budapest, Hungary