Human Use Condition Study- Evaluation of Implanted Leads in Humans

N/ACompletedNCT04320849

Duke University117 enrolled

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.

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

117

Conditions

Pacemaker Malfunction

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

Cedars Sinai Medical Center

Los Angeles, California, United States

MercyOne Iowa Heart Center

Des Moines, Iowa, United States

Minneapolis Heart Institute

Saint Paul, Minnesota, United States

Jackson Heart Clinic

Jackson, Mississippi, United States

Outcomes

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

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.

Time frame: 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.

Time frame: 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.

Time frame: Approximately 1 month

Data from ClinicalTrials.gov

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