Human Use Condition Study- Evaluation of Implanted Leads in Humans

Overview

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.

Full Title of Study: “Human Use Condition Study-Fluoroscopic Evaluation of 3D Curvature of Implanted Right Ventricular Leads in Humans”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: April 30, 2022

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.

Arms, Groups and Cohorts

  • Patients with protocol identified RV Leads
    • Medtronic model 6935M (Quattro Secure Single Coil Defibrillation Lead) Abbott model LDA 210Q (Optisure Single Coil Defibrillation Lead) Abbott model LDA 220Q (Optisure Dual Coil Defibrillation Lead) Boston Scientific model 4470/4471 (FINELINE II/FINELINE II Sterox); Positive Fixation Biotronik model Solia S (Active Fixation Leads)

Clinical Trial Outcome Measures

Primary Measures

  • Number of Participants With in Vivo Cyclic Mean Curvature of Pacing and Defibrillation Leads in the Extravenous Region Determined During Specified Arm Movements
    • Time Frame: 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 Intracardiac Region Determined During Two or More Cardiac Cycles
    • Time Frame: 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.
  • Number of Participants With in Vivo Cyclic Mean Curvature of Pacing and Defibrillation Leads in the Connector Region Determined During Specified Arm Movements
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Duke University
  • Collaborator
    • Abbott
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jonathan Piccini, MD, Principal Investigator, Duke University

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