Evia/Entovis HF-T Master Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01545739
Recruitment Status : Completed
First Posted : March 7, 2012
Last Update Posted : October 16, 2014
Information provided by (Responsible Party):
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.

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

Study Type : Observational
Actual Enrollment : 122 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Master Study of the Evia/Entovis HF-T Pacemaker
Study Start Date : April 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Group/Cohort Intervention/treatment
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

Primary Outcome Measures :
  1. 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)%.

  2. 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 :
  1. 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%.

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01545739

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

Responsible Party: Biotronik SE & Co. KG Identifier: NCT01545739     History of Changes
Other Study ID Numbers: 57
First Posted: March 7, 2012    Key Record Dates
Last Update Posted: October 16, 2014
Last Verified: October 2014

Keywords provided by Biotronik SE & Co. KG:
Pacemaker therapy
Cardiac resynchronisation therapy (CRT)