Human Use Condition Study- Evaluation of Implanted Leads in Humans

NCT04320849 | Completed Results

• 1 other identifier: Pro00103284
• Study Type: observational
• Target: 117
• Locations: 1 country
• Sites: 5

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.

Conditions

Pacemaker Malfunction

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• Abbott: collaborator
• Medtronic: collaborator
• Biotronik SE & Co. KG: collaborator
• Boston Scientific Corporation: collaborator

Study Sites (5)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MercyOne Iowa Heart Center

Des Moines, Iowa, 50266, United States

Location

Minneapolis Heart Institute

Saint Paul, Minnesota, 55102, United States

Location

Jackson Heart Clinic

Jackson, Mississippi, 39216, United States

Location

Trinity Clinic

Tyler, Texas, 75701, United States

Location

Results Point of Contact

• Title: Dr. Jonathan Piccini
• Organization: Duke University Medical Center

jonathan.piccini@duke.edu

919-668-8049

Study Officials

• Jonathan Piccini, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2020
• First Posted: March 25, 2020
• Study Start: June 1, 2021
• Primary Completion: April 30, 2022
• Study Completion: May 23, 2022
• Last Updated: January 19, 2024
• Results First Posted: January 19, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)