Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Abbott | INDUSTRY |
| Medtronic | INDUSTRY |
| Biotronik SE & Co. KG | INDUSTRY |
| Boston Scientific Corporation |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
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
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jonathan Piccini, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | United States | ||
| MercyOne Iowa Heart Center |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Consented Patients With RV Pacing Leads and Defibrillation Leads | Defibrillation leads consisted of the following: Manufacturer: Abbott Model: LDA 210Q Description: Optisure Single Coil Defibrillation Lead Manufacturer: Abbott Model: LDA 220Q Description: Optisure DualCoil Defibrillation Lead Number of Leads Imaged: 8 Manufacturer: Medtronic Model: 6935M Description: Quattro Secure Single Coil Defibrillation Lead Manufacturer: Biotronik Model: Solia S Description: Active Fixation Leads Manufacturer: Boston Scientific Model: 4470 Description: FINELINE II/FINELINE II Sterox EZ Positive Fixation (polyurethane) Manufacturer: Boston Scientific Model: 4471 Description: FINELINE II/FINELINE II Sterox EZ Positive Fixation (polyurethane) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Consented Patients With RV Pacing Leads and Defibrillation Leads | Defibrillation leads consisted of the following: Manufacturer: Abbott Model: LDA 210Q Description: Optisure Single Coil Defibrillation Lead Number of Leads Imaged: 21 Manufacturer: Abbott Model: LDA 220Q Description: Optisure DualCoil Defibrillation Lead Number of Leads Imaged: 8 Manufacturer: Medtronic Model: 6935M Description: Quattro Secure Single Coil Defibrillation Lead Number of Leads Imaged: 27 Manufacturer: Biotronik Model: Solia S Description: Active Fixation Leads Number of Leads Imaged: 23 Manufacturer: Boston Scientific Model: 4470 Description: FINELINE II/FINELINE II Sterox EZ Positive Fixation (polyurethane) Number of Leads Imaged: 1 Manufacturer: Boston Scientific Model: 4471 Description: FINELINE II/FINELINE II Sterox EZ Positive Fixation (polyurethane) Number of Leads Imaged: 31 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Consented patients with imaging data. | Posted | Count of Participants | Participants | Approximately 1 month |
|
30 days from imaging
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Consented Patients With RV Pacing Leads and Defibrillation 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) |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jonathan Piccini | Duke University Medical Center | 919-668-8049 | jonathan.piccini@duke.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 5, 2021 | Jan 17, 2024 | Prot_SAP_000.pdf |
Not provided
| INDUSTRY |
Not provided
Not provided
Not provided
| Des Moines |
| Iowa |
| 50266 |
| United States |
| Minneapolis Heart Institute | Saint Paul | Minnesota | 55102 | United States |
| Jackson Heart Clinic | Jackson | Mississippi | 39216 | United States |
| Trinity Clinic | Tyler | Texas | 75701 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
|
| 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. | Consented patients with imaging data. | Posted | Count of Participants | Participants | 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. | Consented patients with imaging data. | Posted | Count of Participants | Participants | Approximately 1 month |
|
|
|
|
| 0 |
| 117 |
| 0 |
| 117 |
| 0 |
| 117 |
Not provided
Not provided