Management and Detection of Atrial Tachyarrhythmia in Patients Implanted With BIOTRONIK DX Systems

Study Design

  • Multicenter, international, non-controlled, prospective, non-randomized registry
  • This study aims to collect data on efficacy and safety of the single-chamber BIOTRONIK DX system with enhanced atrial diagnostics
  • 2000 patients planned - This study is ongoing
1° Endpoints
  • Frequency and type of AF-related complications
  • Time to occurrence of first AF-related complication
  • Time to AF-related intervention after detection of de novo AF or worsening AF
2° Endpoints
  • Frequency and type of complications related to implantations
  • Frequency and type of lead-related complications
  • All-cause mortality
  • Cardiovascular hospitalization with days in hospital
  • Significance of AF in acute decompensation of HF
Clinical Sites
  • 126 centers planned
Sample Size
  • 2000 patients planned
Inclusion Criteria
  • Indication for implantation of a single chamber ICD (primary or secondary prevention) according to current guidelines
  • Implanted with a BIOTRONIK Lumax 540 VR-T DX ICD with Linoxsmart S DX or successor single chamber DX system within 90 days prior to enrollment
  • Written informed consent, willingness and ability to comply with the protocol
Main Exclusion Criteria
  • Age < 18 years
  • Any limitation to contractual capability
  • Female patients who are pregnant or breast feeding or plan a pregnancy during the course of the study
  • Known active malignant disease or recovered from malignant disease within 2 years prior to enrollment
  • Simultaneous participation in another study
  • Life expectancy < 2 years
  • ICD DX devices and DX leads
  • 2 years
Study Duration
  • 5 years - planned
Reference no.
  • NCT01774357
Principal Investigators
  • Prof. Dr. Gerhard Hindricks, Herzzentrum Leipzig, Germany

Related Products

ICD Teaser

DX Technology

The DX system offers complete atrial diagnostics in a single–lead ICD device, encompassing the benefits of both single and dual-chamber ICDs.