Lumax 740 Master Study

Completed

• Conditions: Safety and Efficacy of the Lumax 740 ICD Family

• Registration Number: NCT01454050
• Lead Sponsor: Biotronik SE & Co. KG

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-10-14
• Study First Submitted QC: 2011-10-17
• Study First Posted: 2011-10-18
• Study Start: 2011-11
• Status Verified: 2012-11
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Last Update Submitted: 2012-11-27
• Last Update Posted: 2012-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 189

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy of the automatic Capture Control feature	PHD, 1-, 3- and 6-month follow-up

Trial Locations

Locations (1)

Medical School Hannover; 🇩🇪 Hannover, Germany