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Post Market Clinical Follow-up of CRT-DX Therapy With Lumax 640/740 HF-T

NCT01930695 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 18

Last updated 2018-04-11

No results posted yet for this study

Summary

The study is designed to collect data of the performance and confirm the safety of the DX (Diagnostic eXtension) functionality in the Lumax 640/470 HF-T in patients with permanent atrial fibrillation and CRT-D indication according to current ESC guidelines. The DX functionality is a feature, which can be activated in the Lumax 640/740 HF-T when connected to the LinoxSMART S DX right ventricular lead. The combination of these devices enable atrial sensing via a sensing dipole in the ventricular lead and therefore reduces the number of implanted leads without sacrificing atrial information. Atrial pacing can not be provided but is not needed in patients with permanent atrial fibrillation.

Conditions

Sponsors & Collaborators

  • Clinical Trial Unit, University Hospital Basel, Switzerland

    collaborator OTHER

  • Biotronik SE & Co. KG

    lead INDUSTRY

Principal Investigators

  • Christian Sticherling, Prof. Dr. · Universitätsspital Basel, Petersgraben 4, 4031 Basel, Switzerland

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2014-10-31
Completion
2014-10-31

Countries

  • Germany
  • Switzerland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01930695 on ClinicalTrials.gov