Medtronic Market-Released DF4 Lead Imaging

Medtronic

Status: Completed

Conditions: Tachycardia

Study type: Observational

Funder types: Industry

Identifiers

NCT01626768

DF4-Imaging-2012

Details and patient eligibility

About

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.

Enrollment: 37 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

37 participants in 1 patient group

Enrolled patients