Lumax DX / Linox DX Evaluation

The objective of this study is to investigate the safety and efficacy of the Lumax DX / Linox DX system.

No hypothesis has been defined.

Completed

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Key information

Conditions

Cardiac Disease Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Charité Uniklinikum Benjamin Franklin

Berlin, 12200, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patient meets the indication for ICD therapy
LVEF ≥ 30%
Patient's compliance with protocol
Signed patient informed consent form

Exclusion criteria

Patient meets one contraindication for ICD therapy
Permanent atrial tachyarrhythmia
Age < 18 years
Cardiac surgery planned within the next 6 months
Life expectancy of less than 6 months
Limited contractual capability
Participating in another clinical study of an investigational cardiac drug or device

Treatment and study plan

Primary outcomes

Rate of appropriate atrial sensing

Time frame: 3 months
Rate of successfully terminated tachyarrhythmia episodes

Time frame: 3 months
Serious adverse device effect rate

Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Biotronik SE & Co. KG

Industry

Registry information

Official study title

Evaluation of the Lumax DX ICD and the Linox DX Lead (ICD=Implantable Cardioverter Defibrillator, DX=Extended Diagnostics)

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: Dec 7, 2011
Registry last updated: Sep 12, 2013

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.

Published trials that share one or more normalized conditions with this study.

Completed