Human Use Condition Study- Evaluation of Implanted Leads in Humans
- Conditions
- Pacemaker Malfunction
- Registration Number
- NCT04320849
- Lead Sponsor
- Duke University
- 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 motion of your previously implanted lead changes in the body.
- 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 the shape and motion of the previously implanted lead changes in the body.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 117
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
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of Participants With in Vivo Cyclic Mean Curvature of Pacing and Defibrillation Leads in the Extravenous Region Determined During Specified Arm Movements Approximately 1 month Measure dynamic in vivo curvature of RV pacing and defibrillator leads in the extravenous and intracardiac anatomy
\*\*\*In vivo cyclic mean curvature of RV pacing and defibrillation leads in the extravenous region will be determined during specified arm movements. The relationship between lead stiffness and curvature will be evaluated.Number of Participants With in Vivo Cyclic Mean Curvature of Pacing and Defibrillation Leads in the Connector Region Determined During Specified Arm Movements Approximately 1 month Assess the relationship between subject and implant variables and lead curvature
\*\*\*In vivo cyclic mean curvature of RV pacing and defibrillation leads in the connector region were determined during specified arm movements. The relationship between lead stiffness and curvature was evaluated.Number of Participants With in Vivo Cyclic Mean Curvature of Pacing and Defibrillation Leads in the Intracardiac Region Determined During Two or More Cardiac Cycles Approximately 1 month Measure the relationship between lead bending stiffness and in vivo curvature
\*\*\*In vivo cyclic mean curvature of RV pacing and defibrillation leads in the intracardiac region will be determined during two or more cardiac cycles. The relationship between lead stiffness and curvature will be evaluated.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
Jackson Heart Clinic
🇺🇸Jackson, Mississippi, United States
Trinity Clinic
🇺🇸Tyler, Texas, United States
Minneapolis Heart Institute
🇺🇸Saint Paul, Minnesota, United States
MercyOne Iowa Heart Center
🇺🇸Des Moines, Iowa, United States
Cedars Sinai Medical Center
🇺🇸Los Angeles, California, United States