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SelectSecure 3830 Lead Imaging

Sponsor
Medtronic Cardiac Rhythm and Heart Failure (Industry)
Overall Status
Completed
CT.gov ID
NCT03941275
Collaborator
(none)
51
Enrollment
4
Locations
29.8
Actual Duration (Months)
12.8
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Bi-plane fluoroscopy

Study Design

Study Type:
Observational
Actual Enrollment :
51 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
SelectSecure 3830 Lead Imaging
Actual Study Start Date :
May 24, 2019
Actual Primary Completion Date :
Nov 3, 2020
Actual Study Completion Date :
Nov 15, 2021

Arms and Interventions

Arm Intervention/Treatment
Subjects undergoing bi-plane fluoroscopy

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Heart Center Research Huntsville Alabama United States 35801
2 Iowa Heart Center West Des Moines Iowa United States 50266
3 Associates in Cardiology PA Silver Spring Maryland United States 20910
4 Lourdes Cardiology Services Voorhees New Jersey United States 08043

Sponsors and Collaborators

  • Medtronic Cardiac Rhythm and Heart Failure

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier:
NCT03941275
Other Study ID Numbers:
  • MDT18066
First Posted:
May 7, 2019
Last Update Posted:
Mar 15, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Heart Diseases

Study Results

No Results Posted as of Mar 15, 2022