Evia/Entovis HF-T Master Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

122 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-04-30

Study Completion Date

2013-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Indication for Cardiac Resynchronization Therapy (CRT)

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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CRT pacemaker implantation

Evia/Entovis HF-T pacemaker for CRT therapy

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No