SelectSecure 3830 Lead Imaging

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03941275

Enrollment

Registered

2019-05-07

Start date

2019-05-24

Completion date

2021-11-15

Last updated

2022-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Diseases

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.

Interventions

DIAGNOSTIC_TESTBi-plane fluoroscopy

In vivo acquisition of biplane cine radiographic images of the market released Medtronic SelectSecure 3830 pacing lead

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026