NCT01545739

Evia/Entovis HF-T Master Study

Master Study of the Evia/Entovis HF-T Pacemaker

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 122 (actual)
• Sponsor: Biotronik SE & Co. KG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Indication for Cardiac Resynchronization Therapy (CRT)

Interventions

Type	Name	Description
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

Timeline

• Start date: 2012-04-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2012-03-07
• Last updated: 2014-10-16

Locations

1 site across 1 country: Hungary