Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Medtronic Market-Released DF4 Lead Imaging

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT01626768
First received: June 19, 2012
Last updated: July 16, 2013
Last verified: July 2013

June 19, 2012
July 16, 2013
June 2012
May 2013   (final data collection date for primary outcome measure)
In vivo lead shape [ Time Frame: Six Months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01626768 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Medtronic Market-Released DF4 Lead Imaging
Not Provided

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.

Not Provided
Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients followed at participating centers.

Tachycardia
Not Provided
Enrolled patients
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37
May 2013
May 2013   (final data collection date for primary outcome measure)

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.
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Saudi Arabia,   United Kingdom
 
NCT01626768
DF4-Imaging-2012
No
Medtronic Cardiac Rhythm Disease Management
Medtronic Cardiac Rhythm Disease Management
Not Provided
Not Provided
Medtronic Cardiac Rhythm Disease Management
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP