SelectSecure 3830 Lead Imaging
1 other identifier
observational
51
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2019
Typical duration for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 1, 2019
CompletedFirst Posted
Study publicly available on registry
May 7, 2019
CompletedStudy Start
First participant enrolled
May 24, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 3, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 15, 2021
CompletedMarch 15, 2022
March 1, 2022
1.4 years
May 1, 2019
March 14, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Acquire accelerometer-based motion data
approximately 30 minutes
Study Arms (1)
Subjects undergoing bi-plane fluoroscopy
Interventions
In vivo acquisition of biplane cine radiographic images of the market released Medtronic SelectSecure 3830 pacing lead
Eligibility Criteria
Subjects of both genders, 18 years of age and older that are currently implanted with at least one SelectSecure 3830 lead, regardless of device type and who meet all inclusion and no exclusion criteria are eligible for the study.
You may qualify if:
- 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
You may not qualify if:
- Subjects who require a legally authorized representative to obtain consent
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Heart Center Research
Huntsville, Alabama, 35801, United States
Iowa Heart Center
West Des Moines, Iowa, 50266, United States
Associates in Cardiology PA
Silver Spring, Maryland, 20910, United States
Lourdes Cardiology Services
Voorhees Township, New Jersey, 08043, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 1, 2019
First Posted
May 7, 2019
Study Start
May 24, 2019
Primary Completion
November 3, 2020
Study Completion
November 15, 2021
Last Updated
March 15, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share