CompletedNot Applicable

Lumax 740 Master Study

Germany189 participantsStarted 2011-11

Plain-language summary

The objective of this study is to prove the safety and efficacy of the Lumax 740 ICD family. Primarily, the newly implemented RV/LV Capture Control algorithm is evaluated, which automatically measures the RV/LV threshold and subsequently adjusts the pacing output.

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: * Inclusion Criteria: Standard indication for single, dual, or triple chamber ICD. * Legal capacity and ability to consent * Signed patient informed consent In addition for HF-T devices: * Bipolar LV-lead with a min. distance of 15 mm between tip and ring * True bipolar RV lead Exclusion Criteria: * Standard contraindication for single, dual, or triple chamber ICD. * 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 any other clinical study of an investigational cardiac drug or device

What they're measuring

Efficacy of the automatic Capture Control feature

Timeframe: PHD, 1-, 3- and 6-month follow-up

Trial details

NCT IDNCT01454050

SponsorBiotronik SE & Co. KG

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2012-11

View on ClinicalTrials.gov More Safety and Efficacy of the Lumax 740 ICD Family trials