Pacemaker Malfunction
Conditions
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.
Interventions
None listed
Sponsors
Abbott
Medtronic
Biotronik SE & Co. KG
Boston Scientific Corporation
Duke University
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With in Vivo Cyclic Mean Curvature of Pacing and Defibrillation Leads in the Extravenous Region Determined During Specified Arm Movements | 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 | 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 117 |
| Total | 117 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Imaging data unavailable | 2 |
| Overall Study | Incomplete imaging | 2 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Consented Patients With RV Pacing Leads and Defibrillation Leads |
|---|---|
| Age, Continuous | 68.72 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 105 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 8 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 17 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 94 Participants |
| Region of Enrollment United States | 117 Participants |
| Sex: Female, Male Female | 40 Participants |
| Sex: Female, Male Male | 77 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 117 |
| other Total, other adverse events | 0 / 117 |
| serious Total, serious adverse events | 0 / 117 |
Outcome results
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.
Time frame: Approximately 1 month
Population: Consented patients with imaging data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Consented Patients With RV Pacing Leads and Defibrillation Leads | Number of Participants With in Vivo Cyclic Mean Curvature of Pacing and Defibrillation Leads in the Connector Region Determined During Specified Arm Movements | 109 Participants |
Comparison: The following set of hypotheses were used to evaluate the relationship between lead stiffness and curvature in the connector region:~H0: a ≥ 0 Ha: a \< 0 where a represents the coefficient for stiffness in the following model: log (curvature) = a\*stiffness + b + normally distributed error.
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.
Time frame: Approximately 1 month
Population: Consented patients with imaging data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Consented Patients With RV Pacing Leads and Defibrillation Leads | Number of Participants With in Vivo Cyclic Mean Curvature of Pacing and Defibrillation Leads in the Extravenous Region Determined During Specified Arm Movements | 109 Participants |
Comparison: The following set of hypotheses were used to evaluate the relationship between lead stiffness and curvature in the extravenous region:~H0: a ≥ 0 Ha: a \< 0 where a represents the coefficient for stiffness in the following model: log (curvature) = a\*stiffness + b + normally distributed error.
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.
Time frame: Approximately 1 month
Population: Consented patients with imaging data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Consented Patients With RV Pacing Leads and Defibrillation Leads | 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 | 109 Participants |
Comparison: The following set of hypotheses will be used to evaluate the relationship between lead stiffness and curvature in the intracardiac region:~H0: a ≥ 0 Ha: a \< 0 where a represents the coefficient for stiffness in the following model: log (curvature) = a\*stiffness + b + normally distributed error.