ead Motion Study

Completed

• Conditions: documentation of lead movement; patients with ICD therapy; 10082206

• Registration Number: NL-OMON41829
• Lead Sponsor: BIOTRONIK SE & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 45

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

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>No primary or secondary endpoints were defined. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Data of interest in addition to the biplane cinefluoroscopy are:<br /><br>- Patient characteristics<br /><br>- ICD/CRT-D therapy characteristics, including data about implantation procedure<br /><br>- X-ray procedural data<br /><br>- Termination of individual patient study participation<br /><br>- Adverse and serious adverse events<br /><br><br /><br>Exploratory data analyses will be used to describe the patient population. </p><br>