SelectSecure 3830 Lead Imaging

Heart Diseases Clinical Trial

Official title:

SelectSecure 3830 Lead Imaging

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03941275
• Other study ID #: MDT18066
• Status: Completed
• Start date: May 24, 2019
• Est. completion date: November 15, 2021

Study information

• Verified date: March 2022
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: November 15, 2021
• Est. primary completion date: November 3, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Diseases

Intervention

Diagnostic Test:
• Bi-plane fluoroscopy
In vivo acquisition of biplane cine radiographic images of the market released Medtronic SelectSecure 3830 pacing lead

Locations

Country	Name	City	State
United States	Heart Center Research	Huntsville	Alabama
United States	Associates in Cardiology PA	Silver Spring	Maryland
United States	Lourdes Cardiology Services	Voorhees	New Jersey
United States	Iowa Heart Center	West Des Moines	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Collect high quality shoulder and intracardiac bi-plane fluoroscopic cine images of the SelectSecure 3830 pacing lead.	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.	approximately 30 minutes
Secondary	Acquire accelerometer-based motion data	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.	approximately 30 minutes