Status:
COMPLETED
Human Use Condition Study- Evaluation of Implanted Leads in Humans
Lead Sponsor:
Duke University
Collaborating Sponsors:
Abbott
Medtronic
Conditions:
Pacemaker Malfunction
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to evaluate different types of leads (wires) that are connected to your pacemaker (an implanted device which assists your heart function) to understand how the shape and m...
Detailed Description
The purpose of this study is to evaluate different types of leads (wires) that are connected to the pacemaker (an implanted device which assists enrolled subject's heart function) to understand how th...
Eligibility Criteria
Inclusion
- Patients with RV leads included in the scope of this study whose system has been implanted for at least 3 calendar months Patients at least 18 years of age and capable of providing informed consent Patients who can physically perform range of arm motion and breath-holding described in the imaging protocol Patients who are willing and able to comply with instruction related to the imaging protocol
Exclusion
- Planned lead modification Patients with abandoned leads (includes: RV/RA/LV) Patients undergoing second or subsequent pulse generator change Patient has permanent atrial arrhythmias Limited life expectancy or medical condition that would not allow completion of the study Patient is known to be pregnant or breastfeeding at time of consent Limited range of mobility of the implant location arm Patient is unable to climb on and off an examination table unassisted Patients deemed hemodynamically unstable
Key Trial Info
Start Date :
June 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 23 2022
Estimated Enrollment :
117 Patients enrolled
Trial Details
Trial ID
NCT04320849
Start Date
June 1 2021
End Date
May 23 2022
Last Update
January 19 2024
Active Locations (5)
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1
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
2
MercyOne Iowa Heart Center
Des Moines, Iowa, United States, 50266
3
Minneapolis Heart Institute
Saint Paul, Minnesota, United States, 55102
4
Jackson Heart Clinic
Jackson, Mississippi, United States, 39216