SelectSecure 3830 Lead Imaging

Completed

• Conditions: Heart Diseases
• Interventions: Diagnostic Test: Bi-plane fluoroscopy

• Registration Number: NCT03941275
• Lead Sponsor: Medtronic Cardiac Rhythm and Heart Failure

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-01
• Study First Submitted QC: 2019-05-06
• Study First Posted: 2019-05-07
• Study Start: 2019-05-24
• Primary Completion: 2020-11-03
• Study Completion: 2021-11-15
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-14
• Last Update Posted: 2022-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects undergoing bi-plane fluoroscopy	Bi-plane fluoroscopy	-

Primary Outcome Measures

Name	Time	Method
Collect high quality shoulder and intracardiac bi-plane fluoroscopic cine images of the SelectSecure 3830 pacing lead.	approximately 30 minutes	Fluoroscopic cine images will be collected in conjunction with a specialized calibration object. When imaging data is processed and analyzed it will characterize the time-varying lead shape changes.

Secondary Outcome Measures

Name	Time	Method
Acquire accelerometer-based motion data	approximately 30 minutes	During fluoroscopy of the two standard arm motions, accelerometer-based motion data will be collected which will allow matching of arm position with lead shape based on the fluoroscopic images.

Trial Locations

Locations (4)

Lourdes Cardiology Services; 🇺🇸 Voorhees, New Jersey, United States

Associates in Cardiology PA; 🇺🇸 Silver Spring, Maryland, United States

Iowa Heart Center; 🇺🇸 West Des Moines, Iowa, United States

Heart Center Research; 🇺🇸 Huntsville, Alabama, United States