Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
51 participants
OBSERVATIONAL
2019-05-24
2021-11-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Subjects undergoing bi-plane fluoroscopy
Bi-plane fluoroscopy
In vivo acquisition of biplane cine radiographic images of the market released Medtronic SelectSecure 3830 pacing lead
Interventions
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Bi-plane fluoroscopy
In vivo acquisition of biplane cine radiographic images of the market released Medtronic SelectSecure 3830 pacing lead
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Medtronic Cardiac Rhythm and Heart Failure
INDUSTRY
Responsible Party
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Locations
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Heart Center Research
Huntsville, Alabama, United States
Iowa Heart Center
West Des Moines, Iowa, United States
Associates in Cardiology PA
Silver Spring, Maryland, United States
Lourdes Cardiology Services
Voorhees Township, New Jersey, United States
Countries
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Other Identifiers
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MDT18066
Identifier Type: -
Identifier Source: org_study_id
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