- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01626768
Medtronic Market-Released DF4 Lead Imaging
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 Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Riyadh, Saudi Arabia
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London, United Kingdom
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Enrolled patients
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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In vivo lead shape
Time Frame: Six Months
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Six Months
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DF4-Imaging-2012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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