Medtronic Market-Released DF4 Lead Imaging

This study has been completed.
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management Identifier:
First received: June 19, 2012
Last updated: July 16, 2013
Last verified: July 2013

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 Type: Observational
Study Design: Time Perspective: Prospective

Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Primary Outcome Measures:
  • In vivo lead shape [ Time Frame: Six Months ] [ Designated as safety issue: No ]

Enrollment: 37
Study Start Date: June 2012
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Enrolled patients


Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients followed at participating centers.


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
Please refer to this study by its identifier: NCT01626768

Saudi Arabia
Riyadh, Saudi Arabia
United Kingdom
London, United Kingdom
Sponsors and Collaborators
Medtronic Cardiac Rhythm Disease Management
  More Information

No publications provided

Responsible Party: Medtronic Cardiac Rhythm Disease Management Identifier: NCT01626768     History of Changes
Other Study ID Numbers: DF4-Imaging-2012
Study First Received: June 19, 2012
Last Updated: July 16, 2013
Health Authority: United Kingdom: Research Ethics Committee
Saudi Arabia: Ethics Committee

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes processed this record on April 20, 2014