CompletedPhase 4

Linox Smart S DX PME/Master Study

Germany116 participantsStarted 2010-03

Plain-language summary

The objective of this study is to prove the safety and efficacy of the Linox smart S DX ICD lead.

Who can participate

Age range18 Years

SexALL

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

Inclusion Criteria: * Patients with standard ICD indication * Be available for follow-up visits on a regular basis at an approved investigational center Exclusion Criteria: * Patients with standard ICD contra-indication * Patients with permanent atrial fibrillation * Have a life expectancy of less than six months * Are expecting to receive cardiac surgery within 6 months after enrollment * Age \< 18 years * Not enrolled in another cardiac clinical investigation

What they're measuring

Rate of atrial adequate sensing

Timeframe: 6 months

Trial details

NCT IDNCT01090401

SponsorBiotronik SE & Co. KG

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-12

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