Clinical trial NCT04320849: Human Use Condition Study- Evaluation of Implanted Leads in Humans
Official title: Human Use Condition Study-Fluoroscopic Evaluation of 3D Curvature of Implanted Right Ventricular Leads in Humans
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pacemaker Malfunction
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Abbott
name: Medtronic
name: Biotronik SE & Co. KG
name: Boston Scientific Corporation
First posted: 2020-03-25
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With in Vivo Cyclic Mean Curvature of Pacing and Defibrillation Leads in the Extravenous Region Determined During Specified Arm Movements
timeFrame: Approximately 1 month
measure: 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
timeFrame: Approximately 1 month
measure: Number of Participants With in Vivo Cyclic Mean Curvature of Pacing and Defibrillation Leads in the Connector Region Determined During Specified Arm Movements
timeFrame: Approximately 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Des Moines
country: United States
facility: MercyOne Iowa Heart Center
state: Iowa
city: Saint Paul
country: United States
facility: Minneapolis Heart Institute
state: Minnesota
city: Jackson
country: United States
facility: Jackson Heart Clinic
state: Mississippi
city: Tyler
country: United States
facility: Trinity Clinic
state: Texas
Study officials:
affiliation: Duke University
name: Jonathan Piccini, MD
role: PRINCIPAL_INVESTIGATOR
References: