Lumax DX / Linox DX Evaluation

Evaluation of the Lumax DX ICD and the Linox DX Lead (ICD=Implantable Cardioverter Defibrillator, DX=Extended Diagnostics)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01486836

Enrollment

Registered

2011-12-07

Start date

2011-11-30

Completion date

2012-09-30

Last updated

2013-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Disease

Keywords

Cardiac disease (ICD indication)

Brief 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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Rate of appropriate atrial sensing	3 months
Rate of successfully terminated tachyarrhythmia episodes	3 months
Serious adverse device effect rate	3 months

Countries

Germany

Outcome results