Medtronic Market-Released DF4 Lead Imaging

This study is not yet open for participant recruitment.

Verified June 2012 by Medtronic Cardiac Rhythm Disease Management

Sponsor:

Information provided by (Responsible Party):

Medtronic Cardiac Rhythm Disease Management

ClinicalTrials.gov Identifier:

NCT01626768

First received: June 19, 2012

Last updated: June 20, 2012

Last verified: June 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

June 19, 2012

Last Updated Date

June 20, 2012

Start Date ^ICMJE

June 2012

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01626768 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Medtronic Market-Released DF4 Lead Imaging

Official Title ^ICMJE

Not Provided

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Patients followed at participating centers.

Condition ^ICMJE

Tachycardia

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Enrolled patients

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2012

Estimated Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

19 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Medtronic DF4 Lead Imaging CRS

medtroniccrmtrials@medtronic.com

Location Countries ^ICMJE

Saudi Arabia, United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT01626768

Other Study ID Numbers ^ICMJE

DF4-Imaging-2012

Has Data Monitoring Committee

Responsible Party

Medtronic Cardiac Rhythm Disease Management

Study Sponsor ^ICMJE

Medtronic Cardiac Rhythm Disease Management

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

Information Provided By

Medtronic Cardiac Rhythm Disease Management

Verification Date

June 2012

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

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