CompletedNot Applicable

Lumax DX / Linox DX Evaluation

Germany38 participantsStarted 2011-11

Plain-language summary

The objective of this study is to investigate the safety and efficacy of the Lumax DX / Linox DX system. No hypothesis has been defined.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Rate of appropriate atrial sensing

Timeframe: 3 months

Rate of successfully terminated tachyarrhythmia episodes

Timeframe: 3 months

Serious adverse device effect rate

Timeframe: 3 months

Trial details

NCT IDNCT01486836

SponsorBiotronik SE & Co. KG

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2012-09

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