Implantable Defibrillator User
Conditions
Brief summary
The purpose of this registry is to confirm the long-term safety and reliability of BIOTRONIK's Plexa ICD lead.
Interventions
None listed
Sponsors
Biotronik, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Successfully implanted with a BIOTRONIK ICD or CRT-D compatible system along with the Plexa lead no more than 30 days prior to consent * Able to understand the nature of the registry and provide informed consent * Available for follow-up visits on a regular basis at the study site for the expected 5 years of follow-up * Accepts BIOTRONIK Home Monitoring® concept * Age greater than or equal to 18 years
Exclusion criteria
* Enrolled in any investigational cardiac device trial * Enrolled in BIOTRONIK's QP ExCELs lead study * Planned cardiac surgical procedures or interventional measures within the next 6 months * Expected to receive heart transplantation or ventricular assist device within 1 year * Life expectancy of less than 1 year * Patients reporting pregnancy at the time of enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Free From Plexa Lead Related Adverse Events | Up to 2.5 years | Evaluate the percentage of subjects without an adverse event related to the Plexa lead through study termination. The endpoint is analyzed as the adverse event free-rate. All protocol defined adverse events that occurred more than 30 days after implant and determined to be related to the Plexa lead plus required invasive intervention to resolve or were related to a lead integrity or clinical performance issue were included. Events meeting this criteria but occurring within 30 days were also included except for lead dislodgement, high pacing threshold, failure to capture, or intermittent capture. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plexa Lead Safety-Individual Adverse Events | Up to 2.5 years | Evaluate the individual types of adverse events contributing to primary outcome measure 'Percentage of Subjects Free From Plexa Lead Related Adverse Events' |
| Sensing Measurements for the Plexa Lead Through Study Termination | Up to 2.5 years | Sensing measurements for the Plexa leads at completed follow-up visits. |
| Pacing Threshold Measurements for the Plexa Lead Through Study Termination | Up to 2.5 years | Pacing threshold measurements at pulse width of 0.4 for the Plexa leads at completed follow-up visits. |
| Shock Impedance for the Plexa Lead Through Study Termination | Up to 2.5 years | Shock impedance measurements for the Plexa leads at completed follow-up visits. |
| Percentage of Subjects Free From Protocol Defined Adverse Events | Up to 2.5 years | Evaluate the percentage of subjects without a protocol defined and clinical event committee adjudicated adverse event, excluding events included in the primary outcome 'Percentage of Subjects Free From Plexa Lead Related Adverse Events', through study termination. Lead dislodgements, high pacing threshold, failure to capture, and intermittent capture related to the Plexa lead that occurred less than or equal to 30 days after lead implant or a lead revision procedure are included here. The endpoint is analyzed as the adverse event free-rate. |
| Pacing Impedance Measurements for the Plexa Lead Through Study Termination | Up to 2.5 years | Pacing impedance measurements for the Plexa leads at completed follow-up visits. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BIOTRONIK Plexa ICD Lead Subjects consented and implanted with a BIOTRONIK ICD or CRT-D pulse generator and a Plexa lead. | 901 |
| Total | 901 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 64 |
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Physician Decision | 57 |
| Overall Study | Plexa Lead or Pulse Generator Extraction | 10 |
| Overall Study | Study Closure | 757 |
| Overall Study | Withdrawal by Subject | 10 |
Baseline characteristics
| Characteristic | BIOTRONIK Plexa ICD Lead | — |
|---|---|---|
| Age, Continuous | 64.35 years STANDARD_DEVIATION 12.59 | — |
| Height | 68.5 inches STANDARD_DEVIATION 4 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 237 Participants | — |
| Sex: Female, Male Male | 657 Participants | — |
| Weight | 207.2 pounds STANDARD_DEVIATION 57 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 64 / 901 |
| other Total, other adverse events | 12 / 901 |
| serious Total, serious adverse events | 44 / 901 |
Outcome results
Primary
Percentage of Subjects Free From Plexa Lead Related Adverse Events
Evaluate the percentage of subjects without an adverse event related to the Plexa lead through study termination. The endpoint is analyzed as the adverse event free-rate. All protocol defined adverse events that occurred more than 30 days after implant and determined to be related to the Plexa lead plus required invasive intervention to resolve or were related to a lead integrity or clinical performance issue were included. Events meeting this criteria but occurring within 30 days were also included except for lead dislodgement, high pacing threshold, failure to capture, or intermittent capture.
Time frame: Up to 2.5 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BIOTRONIK Plexa ICD Lead | Percentage of Subjects Free From Plexa Lead Related Adverse Events | 100.00 percentage of participants |
Secondary
Pacing Impedance Measurements for the Plexa Lead Through Study Termination
Pacing impedance measurements for the Plexa leads at completed follow-up visits.
Time frame: Up to 2.5 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BIOTRONIK Plexa ICD Lead | Pacing Impedance Measurements for the Plexa Lead Through Study Termination | 567.1 ohms | Standard Deviation 111.2 |
Secondary
Pacing Threshold Measurements for the Plexa Lead Through Study Termination
Pacing threshold measurements at pulse width of 0.4 for the Plexa leads at completed follow-up visits.
Time frame: Up to 2.5 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BIOTRONIK Plexa ICD Lead | Pacing Threshold Measurements for the Plexa Lead Through Study Termination | 0.63 V | Standard Deviation 0.28 |
Secondary
Percentage of Subjects Free From Protocol Defined Adverse Events
Evaluate the percentage of subjects without a protocol defined and clinical event committee adjudicated adverse event, excluding events included in the primary outcome 'Percentage of Subjects Free From Plexa Lead Related Adverse Events', through study termination. Lead dislodgements, high pacing threshold, failure to capture, and intermittent capture related to the Plexa lead that occurred less than or equal to 30 days after lead implant or a lead revision procedure are included here. The endpoint is analyzed as the adverse event free-rate.
Time frame: Up to 2.5 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BIOTRONIK Plexa ICD Lead | Percentage of Subjects Free From Protocol Defined Adverse Events | 95.12 percentage of participants |
Secondary
Plexa Lead Safety-Individual Adverse Events
Evaluate the individual types of adverse events contributing to primary outcome measure 'Percentage of Subjects Free From Plexa Lead Related Adverse Events'
Time frame: Up to 2.5 years
Population: No primary outcome adverse events were reported; therefore, there are no individual events to be analyzed.
Secondary
Sensing Measurements for the Plexa Lead Through Study Termination
Sensing measurements for the Plexa leads at completed follow-up visits.
Time frame: Up to 2.5 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BIOTRONIK Plexa ICD Lead | Sensing Measurements for the Plexa Lead Through Study Termination | 15.88 mV | Standard Deviation 5.56 |
Secondary
Shock Impedance for the Plexa Lead Through Study Termination
Shock impedance measurements for the Plexa leads at completed follow-up visits.
Time frame: Up to 2.5 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BIOTRONIK Plexa ICD Lead | Shock Impedance for the Plexa Lead Through Study Termination | 75.1 ohms | Standard Deviation 13.7 |