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Medtronic Market-Released DF4 Lead Imaging

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ClinicalTrials.gov Identifier: NCT01626768
Recruitment Status : Completed
First Posted : June 25, 2012
Last Update Posted : July 17, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease
Tachycardia

Study Design

Study Type : Observational
Actual Enrollment : 37 participants
Time Perspective: Prospective
Study Start Date : June 2012
Primary Completion Date : May 2013
Study Completion Date : May 2013
Groups and Cohorts

Group/Cohort
Enrolled patients


Outcome Measures

Primary Outcome Measures :
  1. In vivo lead shape [ Time Frame: Six Months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients followed at participating centers.
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01626768


Locations
Saudi Arabia
Riyadh, Saudi Arabia
United Kingdom
London, United Kingdom
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
More Information

Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT01626768     History of Changes
Other Study ID Numbers: DF4-Imaging-2012
First Posted: June 25, 2012    Key Record Dates
Last Update Posted: July 17, 2013
Last Verified: July 2013

Additional relevant MeSH terms:
Tachycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes