Human Use Condition Study- Evaluation of Implanted Leads in Humans

Study Overview
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Brief Summary
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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
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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.

Official Title
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Human Use Condition Study-Fluoroscopic Evaluation of 3D Curvature of Implanted Right Ventricular Leads in Humans

Conditions
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Pacemaker Malfunction

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with Biotronik Leads<br>Patients with these models: LSiello S, Solia S Description: Active Fixation Leads | |
| Patients with Boston Scientific Leads<br>Patients with these models: 4452, 4453, 4456, 4457 Description: FINELINE II/FINELINE II Sterox Passive Fixation (polyurethane) Boston Scientific 4463, 4464, 4465, 4469, 4470, 4471 FINELINE II/FINELINE II Sterox EZ Positive Fixation (polyurethane) | |
| Patients with Abbott Leads<br>Patients with these models: LDA 210Q Description: Optisure Single Coil Defibrillation Lead | |
| Patients with Medtronic Leads<br>Patients with these model: 6935M Description:Quattro Secure Single Coil Defibrillation Lead | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In vivo cyclic curvature and mean curvature of pacing and defibrillation leads in the extravenous region will be determined during specified arm movements. | Measure dynamic in vivo curvature of RV pacing and defibrillator leads in the extravenous and intracardiac anatomy | Approximately 1 month | 
| In vivo cyclic curvature and mean curvature of pacing and defibrillation leads in the intracardiac region will be determined during two or more cardiac cycles. | Measure the relationship between lead bending stiffness and in vivo curvature | Approximately 1 month | 
| In vivo cyclic curvature and mean curvature of pacing and defibrillation leads in the connector region will be determined during specified arm movements. | Assess the relationship between subject and implant variables and lead curvature | Approximately 1 month |