Human Use Condition Study- Evaluation of Implanted Leads in Humans
Completed
Conditions studied: Pacemaker Malfunction
In brief
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 motion of your previously implanted lead changes in the body.
Key facts
- Study ID
- NCT04320849
- Run by
- Duke University
- People needed
- 117
- Starts
- 2021-06-01
- Expected to finish
- 2022-05-23
- Last updated by the study team
- 2024-01-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Cedars Sinai Medical Center — Los Angeles, California, United States
- MercyOne Iowa Heart Center — Des Moines, Iowa, United States
- Minneapolis Heart Institute — Saint Paul, Minnesota, United States
- Jackson Heart Clinic — Jackson, Mississippi, United States
- Trinity Clinic — Tyler, Texas, United States
Full record on ClinicalTrials.gov
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