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Clinical Trials/NL-OMON41829
NL-OMON41829
Completed
Not Applicable

ead Motion Study - Lead Motion Study

BIOTRONIK SE & Co. KG0 sites45 target enrollmentTBD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
documentation of lead movement
Sponsor
BIOTRONIK SE & Co. KG
Enrollment
45
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Observational invasive

Investigators

Eligibility Criteria

Inclusion Criteria

  • · Patient has provided written informed consent
  • · Patient has a BIOTRONIK ICD or CRT\-D
  • · Patient has at least a BIOTRONIK Linoxsmart S\-DX lead or any other BIOTRONIK lead model
  • · Data about the implantation of the ICD/CRT\-D, the lead(s) and the implanting physician are available at the investigation site
  • · Patient is able to attend the X\-ray procedure following a routine follow\-up visit
  • · None of the leads was implanted within the last three months
  • · Patient had no cardiac intervention within the last two months
  • · Patient has legal capacity and ability to consent

Exclusion Criteria

  • · Age \<18 years
  • · Patient is pregnant or breastfeeding
  • · Any complication of the implanted system at the time of enrollment
  • · Applicable patient subgroup is closed for enrollment

Outcomes

Primary Outcomes

Not specified

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