Completed

NCT Number: NCT04320849

Human Use Condition Study- Evaluation of Implanted 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.

Completed

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Key information

Conditions

Pacemaker Malfunction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cedars Sinai Medical Center, Los Angeles, California, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

Abbott
Biotronik SE & Co. KG
Boston Scientific Corporation
Medtronic

Registry information

Official study title

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

Acronym: HUCS

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Mar 25, 2020
Registry last updated: Jan 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.