Evia/Entovis HF-T Master Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biotronik SE & Co. KG
ClinicalTrials.gov Identifier:
NCT01545739
First received: March 1, 2012
Last updated: December 4, 2013
Last verified: December 2013
  Purpose

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: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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)
Arms 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01545739

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

No publications provided

Responsible Party: Biotronik SE & Co. KG
ClinicalTrials.gov Identifier: NCT01545739     History of Changes
Other Study ID Numbers: 57
Study First Received: March 1, 2012
Last Updated: December 4, 2013
Health Authority: Austria: AGES, Bundesamt für Sicherheit im Gesundheitswesen

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

ClinicalTrials.gov processed this record on August 21, 2014