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Completed

NCT Number: NCT01626768

Medtronic Market-Released DF4 Lead Imaging

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.

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Key information

Conditions

Tachycardia Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Riyadh, Saudi Arabia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. In vivo lead shape

    Time frame: Six Months

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 25, 2012
Registry last updated
Jul 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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