Lumax 740 Master Study

Biotronik

Status: Completed

Conditions: Safety and Efficacy of the Lumax 740 ICD Family

Study type: Observational

Funder types: Industry

Identifiers

NCT01454050

55

Details and patient eligibility

About

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.

Enrollment: 189 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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