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NCT01626768 Clinical Trial

Medtronic Market-Released DF4 Lead Imaging

Tachycardia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01626768
Other study ID # DF4-Imaging-2012
Secondary ID
Status Completed
Phase N/A
First received June 19, 2012
Last updated July 16, 2013
Start date June 2012
Est. completion date May 2013

Study information
Verified date July 2013
Source Medtronic Cardiac Rhythm Disease Management
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Research Ethics CommitteeSaudi Arabia: Ethics Committee
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 37
Est. completion date May 2013
Est. primary completion date May 2013
Accepts healthy volunteers No
Gender Both
Age group 19 Years and older
Eligibility 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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Medtronic Cardiac Rhythm Disease Management

Countries where clinical trial is conducted

Saudi Arabia,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary In vivo lead shape Six Months No
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