Evia/Entovis HF-T Master Study

Master Study of the Evia/Entovis HF-T Pacemaker

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01545739

Enrollment

122

Registered

2012-03-07

Start date

2012-04-30

Completion date

2013-12-31

Last updated

2014-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Indication for Cardiac Resynchronization Therapy (CRT)

Keywords

Pacemaker therapy, Cardiac resynchronisation therapy (CRT)

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.

Interventions

DEVICEEvia/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

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Safety: Serious Adverse Device Effect (SADE) free rate	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)	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

Measure	Time frame	Description
Efficacy of the left ventricular capture control feature (focus on pulse amplitude adjustment)	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%.

Countries

Hungary

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026