SelectSecure 3830 Lead Imaging

Medtronic

Status: Completed

Conditions: Heart Diseases

Treatments: Diagnostic Test: Bi-plane fluoroscopy

Study type: Observational

Funder types: Industry

Identifiers

NCT03941275

MDT18066

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

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

Trial design

51 participants in 1 patient group

Subjects undergoing bi-plane fluoroscopy

Treatment:

Diagnostic Test: Bi-plane fluoroscopy