Human Use Condition Study- Evaluation of Implanted Leads in Humans

Pacemaker Malfunction Clinical Trial

— HUCS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04320849
• Other study ID #: Pro00103284
• Status: Completed
• Start date: June 1, 2021
• Est. completion date: May 23, 2022

Study information

• Verified date: January 2024
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: May 23, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pacemaker Malfunction

Locations

Country	Name	City	State
United States	MercyOne Iowa Heart Center	Des Moines	Iowa
United States	Jackson Heart Clinic	Jackson	Mississippi
United States	Cedars Sinai Medical Center	Los Angeles	California
United States	Minneapolis Heart Institute	Saint Paul	Minnesota
United States	Trinity Clinic	Tyler	Texas

Sponsors (5)

Lead Sponsor	Collaborator
Duke University	Abbott, Biotronik SE & Co. KG, Boston Scientific Corporation, Medtronic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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