An observational study in Heart Diseases, sponsored by Medtronic Cardiac Rhythm and Heart Failure. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-15.
Sponsored by Medtronic Cardiac Rhythm and Heart Failure · Observational
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.
3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.
This study's enrollment of 51 is below the median of 294 across 1,241 observational studies indexed under Heart Diseases.
Browse Heart Diseases studies →Medtronic Cardiac Rhythm and Heart Failure is the lead sponsor of 239 studies on the registry; 6 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 17 (89%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Diagnostic Test: Bi-plane fluoroscopy
In vivo acquisition of biplane cine radiographic images of the market released Medtronic SelectSecure 3830 pacing lead
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.
Time frame: approximately 30 minutes
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.
Time frame: approximately 30 minutes
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Medtronic Cardiac Rhythm and Heart Failure