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OpenTrials
Completed

NCT Number: NCT03941275

SelectSecure 3830 Lead Imaging

This study is designed to collect high-quality shoulder and intracardiac bi-plane fluoroscopic images during two standard arm motions on patients implanted with a market released SelectSecure 3830 lead for the purposes of developing a fracture reliability model.

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Key information

Conditions

Heart Diseases Cardiovascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Heart Center Research, Huntsville, Alabama, United States

Loading trial locations.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who are at least 18 years of age
  • Patient has a pacing, ICD or CRT system incorporating at least one SelectSecure 3830 lead in the right atrium or right ventricle
  • Patients able and willing to attend imaging session
  • Patients able and willing to give informed consent
  • Pacing capture threshold and pacing impedance of the lead are within normal range at the time of enrollment
  • Patient must be able to accomplish arm flexion and adduction past 90 degrees

Exclusion criteria

  • Subjects who require a legally authorized representative to obtain consent
  • Subjects with exclusion criteria required by local law (e.g. age, breastfeeding)
  • Pregnant women, or women of child bearing potential and who are not on a reliable form of birth control
  • Subjects that were implanted with a pacing, ICD, CRT device and/or cardiac leads less than three months ago

Treatment and study plan

Bi-plane fluoroscopy

Diagnostic Test

In vivo acquisition of biplane cine radiographic images of the market released Medtronic SelectSecure 3830 pacing lead

Primary outcomes

  1. Collect high quality shoulder and intracardiac bi-plane fluoroscopic cine images of the SelectSecure 3830 pacing lead.

    Time frame: approximately 30 minutes

    Fluoroscopic cine images will be collected in conjunction with a specialized calibration object. When imaging data is processed and analyzed it will characterize the time-varying lead shape changes.

Secondary outcomes

  1. Acquire accelerometer-based motion data

    Time frame: approximately 30 minutes

    During fluoroscopy of the two standard arm motions, accelerometer-based motion data will be collected which will allow matching of arm position with lead shape based on the fluoroscopic images.

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
May 7, 2019
Registry last updated
Mar 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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