Lumax DX / Linox DX Evaluation

Completed

• Conditions: Cardiac Disease

• Registration Number: NCT01486836
• Lead Sponsor: Biotronik SE & Co. KG

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-15
• Study First Submitted QC: 2011-12-05
• Study First Posted: 2011-12-07
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-11
• Last Update Posted: 2013-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Charité Uniklinikum Benjamin Franklin; 🇩🇪 Berlin, Germany