Lumax DX / Linox DX Evaluation

Biotronik

Status: Completed

Conditions: Cardiac Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT01486836

58

Details and patient eligibility

About

The objective of this study is to investigate the safety and efficacy of the Lumax DX / Linox DX system.

No hypothesis has been defined.

Enrollment: 38 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

38 participants in 1 patient group

ICD therapy