Evia/Entovis HF-T Master Study

Master Study of the Evia/Entovis HF-T Pacemaker

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.

Study Overview

• Status: Completed
• Conditions: Indication for Cardiac Resynchronization Therapy (CRT)
• Intervention / Treatment: Device: Evia/Entovis HF-T pacemaker for CRT therapy

• Study Type: Observational
• Enrollment (Actual): 122

Contacts and Locations

Study Locations

• Hungary
  • Budapest, Hungary, 1122
    • Semmelweis University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with indication for CRT therapy

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety: Serious Adverse Device Effect (SADE) free rate	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)%.	Until 3 month follow-up
Efficacy of the left ventricular capture control feature (focus on threshold measurements)	Absolute difference between the triggered automatic and manual pacing threshold in the left ventricle is smaller than 0.3 Volt.	At pre-hospital discharge, 1 and 3 month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of the left ventricular capture control feature (focus on pulse amplitude adjustment)	Rate of appropriate adjustment of the left ventricular (LV) pulse amplitude by the LV capture control feature is greater than 90%.	1 and 3 month follow-up

Collaborators and Investigators

• Sponsor: Biotronik SE & Co. KG

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: March 1, 2012
• First Submitted That Met QC Criteria: March 6, 2012
• First Posted (Estimate): March 7, 2012

Study Record Updates

• Last Update Posted (Estimate): October 16, 2014
• Last Update Submitted That Met QC Criteria: October 15, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: Pacemaker therapy; Cardiac resynchronisation therapy (CRT)
• Other Study ID Numbers: 57

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No