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Clinical Trials/NCT01626768
NCT01626768CompletedNot Applicable

Medtronic Market-Released DF4 Lead Imaging

Medtronic Cardiac Rhythm and Heart Failure0 sites37 target enrollmentStarted: June 2012Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
37
Primary Endpoint
In vivo lead shape
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The Medtronic Market-Released DF4 Lead Imaging Study is a prospective, non-randomized study, multi-center clinical investigation.

The purpose of this clinical investigation is to collect high quality medical images of the Medtronic Market-Released DF4 lead in the shoulder and heart. Images collected during the study will allow for lead design and testing processes better tailored to the implanted environment.

Study Design

Study Type
Observational
Time Perspective
Prospective

Eligibility Criteria

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

Inclusion Criteria

  • •Patients greater than 18 years of age.
  • •Patients able and willing to attend imaging session.
  • •Patients able and willing to give informed consent.
  • •Patients with an implanted device/lead(s) for a minimum of 3 months.

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.

Outcomes

Primary Outcomes

In vivo lead shape

Time Frame: Six Months

Secondary Outcomes

No secondary outcomes reported

Investigators

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

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