We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Medtronic Market-Released DF4 Lead Imaging

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01626768
First Posted: June 25, 2012
Last Update Posted: July 17, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure
  Purpose

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
Tachycardia

Study Type: Observational
Study Design: Time Perspective: Prospective

Further study details as provided by Medtronic Cardiac Rhythm and Heart Failure:

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

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)
Groups/Cohorts
Enrolled patients

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 Submitted: June 19, 2012
First Posted: June 25, 2012
Last Update Posted: July 17, 2013
Last Verified: July 2013

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