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Evia/Entovis HF-T Master Study

NCT01545739 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 122

Last updated 2014-10-16

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Biotronik SE & Co. KG

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • Hungary

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01545739 on ClinicalTrials.gov