Human Use Condition Study- Evaluation of Implanted Leads in Humans (HUCS)

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

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.

Study Overview

• Status: Completed
• Conditions: Pacemaker Malfunction

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.

• Study Type: Observational
• Enrollment (Actual): 117

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars Sinai Medical Center
  • Iowa
    • Des Moines, Iowa, United States, 50266
      • MercyOne Iowa Heart Center
  • Minnesota
    • Saint Paul, Minnesota, United States, 55102
      • Minneapolis Heart Institute
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • Jackson Heart Clinic
  • Texas
    • Tyler, Texas, United States, 75701
      • Trinity Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study will enroll at least 80 and up to 120 subjects with one of four different specified market-released lead families. The leads are from all four CIED manufacturers participating in this protocol. Approximately 30 leads from each manufacturer's lead family will be required.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With in Vivo Cyclic Mean Curvature of Pacing and Defibrillation Leads in the Extravenous Region Determined During Specified Arm Movements	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.	Approximately 1 month
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	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.	Approximately 1 month
Number of Participants With in Vivo Cyclic Mean Curvature of Pacing and Defibrillation Leads in the Connector Region Determined During Specified Arm Movements	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.	Approximately 1 month

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Boston Scientific Corporation; Medtronic; Abbott; Biotronik SE & Co. KG
• Investigators: Principal Investigator: Jonathan Piccini, MD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Actual): April 30, 2022
• Study Completion (Actual): May 23, 2022

Study Registration Dates

• First Submitted: March 23, 2020
• First Submitted That Met QC Criteria: March 23, 2020
• First Posted (Actual): March 25, 2020

Study Record Updates

• Last Update Posted (Estimated): January 19, 2024
• Last Update Submitted That Met QC Criteria: January 17, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: Pro00103284

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No