Lumax DX / Linox DX Evaluation

Biotronik SE & Co. KG38 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Cardiac Disease

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Charité Uniklinikum Benjamin Franklin

Berlin, Germany

Outcomes

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

Data from ClinicalTrials.gov

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