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Evia/Entovis HF-T Master Study

This study has been completed.
Information provided by (Responsible Party):
Biotronik SE & Co. KG Identifier:
First received: March 1, 2012
Last updated: October 15, 2014
Last verified: October 2014
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.

Condition Intervention
Indication for Cardiac Resynchronization Therapy (CRT)
Device: Evia/Entovis HF-T pacemaker for CRT therapy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Master Study of the Evia/Entovis HF-T Pacemaker

Further study details as provided by Biotronik SE & Co. KG:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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%.

Enrollment: 122
Study Start Date: April 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with indication for CRT therapy

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01545739

Semmelweis University
Budapest, Hungary, 1122
Sponsors and Collaborators
Biotronik SE & Co. KG
  More Information

Responsible Party: Biotronik SE & Co. KG Identifier: NCT01545739     History of Changes
Other Study ID Numbers: 57
Study First Received: March 1, 2012
Last Updated: October 15, 2014

Keywords provided by Biotronik SE & Co. KG:
Pacemaker therapy
Cardiac resynchronisation therapy (CRT) processed this record on May 25, 2017