Medtronic Market-Released DF4 Lead Imaging

Medtronic Cardiac Rhythm and Heart Failure37 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Tachycardia

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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.

Locations (2)

Unnamed facility

Riyadh, Saudi Arabia

Unnamed facility

London, United Kingdom

Outcomes

Primary Outcomes

In vivo lead shape

Time frame: Six Months

Data from ClinicalTrials.gov

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