SelectSecure 3830 Lead Imaging

Completed

Conditions studied: Heart Diseases

In brief

This study is designed to collect high-quality shoulder and intracardiac bi-plane fluoroscopic images during two standard arm motions on patients implanted with a market released SelectSecure 3830 lead for the purposes of developing a fracture reliability model.

Key facts

Study ID

NCT03941275

Run by

Medtronic Cardiac Rhythm and Heart Failure

People needed

51

Starts

2019-05-24

Expected to finish

2021-11-15

Last updated by the study team

2022-03-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients who are at least 18 years of age
• Patient has a pacing, ICD or CRT system incorporating at least one SelectSecure 3830 lead in the right atrium or right ventricle
• Patients able and willing to attend imaging session
• Patients able and willing to give informed consent
• Pacing capture threshold and pacing impedance of the lead are within normal range at the time of enrollment
• Patient must be able to accomplish arm flexion and adduction past 90 degrees

You may not qualify if…

• 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
• Subjects that were implanted with a pacing, ICD, CRT device and/or cardiac leads less than three months ago

Where it is running

• Heart Center Research — Huntsville, Alabama, United States
• Iowa Heart Center — West Des Moines, Iowa, United States
• Associates in Cardiology PA — Silver Spring, Maryland, United States
• Lourdes Cardiology Services — Voorhees Township, New Jersey, United States

Full record on ClinicalTrials.gov

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