Completed

NCT Number: NCT01545739

Evia/Entovis HF-T Master Study

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.

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Key information

Conditions

Indication for Cardiac Resynchronization Therapy (CRT)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Semmelweis University

Budapest, 1122, Hungary

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Evia/Entovis HF-T pacemaker for CRT therapy

Device

Implantation of CRT pacemaker and standard follow-ups at pre-hospital discharge, and after 1, 3 and 6 months

Primary outcomes

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 outcomes

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%.

Sponsors and collaborators

Lead sponsor

Biotronik SE & Co. KG

Industry

Registry information

Official study title

Master Study of the Evia/Entovis HF-T Pacemaker

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: Mar 7, 2012
Registry last updated: Oct 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.