Lumax 740 Master Study

Biotronik SE & Co. KG189 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

189

Conditions

Safety and Efficacy of the Lumax 740 ICD Family

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Medical School Hannover

Hanover, Germany

Outcomes

Primary Outcomes

Efficacy of the automatic Capture Control feature

Time frame: PHD, 1-, 3- and 6-month follow-up

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.