Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Duke University
With
Abbott
Medtronic
Biotronik SE & Co. KG
Boston Scientific Corporation
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 the shape and motion of the previously implanted lead changes in the body.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
Clareo Health | Human Use Condition Study- Evaluation of Implanted Leads in Humans
