Skip to main content
Clinical Trials/NCT01774357
NCT01774357CompletedNot Applicable

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

Biotronik SE & Co. KG1 site in 1 country2,054 target enrollmentStarted: January 2013Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
2,054
Locations
1
Primary Endpoint
Frequency and types of AF-related complications

Study Overview

Brief Summary

This is an observational registry study aiming to collect data on efficacy and safety of the single chamber Biotronik DX system with enhanced atrial diagnostics. The minimal follow-up period is 24 months. All analyses on the data will be done post-hoc; the study does not intend to confirm any pre-specified hypotheses.

Detailed Description

Enrollment (E0)

Timing:

• The enrollment (date of patient written informed consent) starts after implantation of a BIOTRONIK Lumax 540 VR-T DX ICD with Linoxsmart S DX or successor single chamber DX system according to current guidelines (primary or secondary prevention) but should not be later than 90 days after implantation.

Procedures:

  • Check inclusion and exclusion criteria
  • Patient information and written informed consent process
  • Assignment of a unique study code
  • ICD interrogation (re-programming if necessary)
  • HMSC registration (recommended)
  • Investigator assessment: appropriate atrial sensing

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

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

Outcomes

Primary Outcomes

Frequency and types of AF-related complications

Time Frame: 24 months

Time to occurrence of first AF-related complication

Time Frame: 24 months

Time to AF-related intervention after detection of de novo or worsening AF

Time Frame: 24 months

Secondary Outcomes

  • All-cause mortality(24 months)
  • Frequency and type of complications related to implantation(24 months)
  • Significance of AF in acute decompensation of heart failure(24 months)
  • Interventions based on Home Monitoring information regarding AF(24 months)
  • Cardiovascular hospitalization with days in hospital(24 months)
  • Frequency and type of lead-related complications(24 months)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials