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Clinical Trials/NCT03941275
NCT03941275CompletedNot Applicable

SelectSecure 3830 Lead Imaging

Medtronic Cardiac Rhythm and Heart Failure4 sites in 1 country51 target enrollmentStarted: May 24, 2019Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
51
Locations
4
Primary Endpoint
Collect high quality shoulder and intracardiac bi-plane fluoroscopic cine images of the SelectSecure 3830 pacing lead.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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.

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Prospective

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

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

  • Acquire accelerometer-based motion data(approximately 30 minutes)

Investigators

Sponsor
Medtronic Cardiac Rhythm and Heart Failure
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (4)

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