Implantable Defibrillator User
Conditions
Brief summary
The purpose of this registry study is to confirm the long-term safety and reliability of the Protego DF4 right ventricular 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
* Implanted within the last 30 days or candidate for implantation of a BIOTRONIK ICD or CRT-D DF4 compatible system along with the Protego DF4 lead * Meets ICD or CRT-D system implant recommendations as defined in guidelines published by relevant professional societies * Able to understand the nature of the registry and provide informed consent * Available for follow-up visits on a regular basis at the investigational site for the expected 5 years of follow-up * Age greater than or equal to 18 years
Exclusion criteria
* Enrolled in any investigational cardiac device trial * 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 * Presence of another life-threatening, underlying illness separate from their cardiac disorder * Patients reporting pregnancy at the time of enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With No Protego DF4 Lead Adverse Event | Up to 4.5 years | Evaluate the percentage of subjects without an adverse event related to the Protego DF4 lead or header through 5 years. The endpoint is analyzed as the adverse event free-rate. |
| Protego DF4 Lead Safety-Individual Adverse Event-Free Rate | Up to 4.5 years | Evaluate the individual types of adverse events contributing to primary outcome measure 'Protego DF4 Lead Safety-Overall Adverse Event-Free Rate'. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With no Adverse Events Excluded From Primary Objectives | Up to 4.5 years | The overall percentage of patients without adverse events that were excluded from the primary objectives and occurred through 5 years of follow-up. This was evaluated as an adverse event free-rate (AEFR). |
| Protego DF4 Lead Pacing Threshold Measurement | Up to 4.5 years | Pacing threshold measurements at pulse width of 0.4 or 0.5 ms for the Protego DF4 leads through 5 years of follow-up. |
| Protego DF4 Lead Pacing Impedance | Up to 4.5 years | Pacing impedance measurements for the Protego DF4 leads through 5 years of follow-up. |
| Protego DF4 Lead Sensing | Up to 4.5 years | Sensing measurements for the Protego DF4 leads through 5 years of follow-up. |
| Protego DF4 Lead Shock Impedance | Up to 4.5 years | Shock impedance measurements for the Protego DF4 leads through 5 years of follow-up. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BIOTRONIK Protego DF4 Lead Patients with a Protego DF4 lead used in conjunction with any market-released BIOTRONIK ICD or cardiac resynchronization therapy defibrillator device with a DF4 header. | 1,694 |
| Total | 1,694 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 282 |
| Overall Study | Lost to Follow-up | 57 |
| Overall Study | Study Terminated for EP PASSION | 961 |
| Overall Study | Subject No Longer has Study System | 42 |
| Overall Study | Subject Withdrawn by Investigator | 273 |
| Overall Study | Withdrawal by Subject | 79 |
Baseline characteristics
| Characteristic | BIOTRONIK Protego DF4 Lead |
|---|---|
| Age, Continuous | 65.5 years STANDARD_DEVIATION 12.49 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 177 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1326 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 191 Participants |
| Height | 67.7 inches STANDARD_DEVIATION 4.11 |
| Race (NIH/OMB) American Indian or Alaska Native | 7 Participants |
| Race (NIH/OMB) Asian | 31 Participants |
| Race (NIH/OMB) Black or African American | 340 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 5 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 181 Participants |
| Race (NIH/OMB) White | 1130 Participants |
| Sex: Female, Male Female | 481 Participants |
| Sex: Female, Male Male | 1213 Participants |
| Weight | 196.3 pounds STANDARD_DEVIATION 51.28 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 282 / 1,694 |
| other Total, other adverse events | 144 / 1,694 |
| serious Total, serious adverse events | 145 / 1,694 |
Outcome results
Primary
Percentage of Subjects With No Protego DF4 Lead Adverse Event
Evaluate the percentage of subjects without an adverse event related to the Protego DF4 lead or header through 5 years. The endpoint is analyzed as the adverse event free-rate.
Time frame: Up to 4.5 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BIOTRONIK Protego DF4 Lead | Percentage of Subjects With No Protego DF4 Lead Adverse Event | 98.7 percentage of participants |
Primary
Protego DF4 Lead Safety-Individual Adverse Event-Free Rate
Evaluate the individual types of adverse events contributing to primary outcome measure 'Protego DF4 Lead Safety-Overall Adverse Event-Free Rate'.
Time frame: Up to 4.5 years
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BIOTRONIK Protego DF4 Lead | Protego DF4 Lead Safety-Individual Adverse Event-Free Rate | Lead oversensing | 0.41 percentage of participants |
| BIOTRONIK Protego DF4 Lead | Protego DF4 Lead Safety-Individual Adverse Event-Free Rate | Lead conductor fracture | 0.30 percentage of participants |
| BIOTRONIK Protego DF4 Lead | Protego DF4 Lead Safety-Individual Adverse Event-Free Rate | Lead dislodgement | 0.18 percentage of participants |
| BIOTRONIK Protego DF4 Lead | Protego DF4 Lead Safety-Individual Adverse Event-Free Rate | Lead impedance our of range, high | 0.12 percentage of participants |
| BIOTRONIK Protego DF4 Lead | Protego DF4 Lead Safety-Individual Adverse Event-Free Rate | Lead impedance out of range, low | 0.12 percentage of participants |
| BIOTRONIK Protego DF4 Lead | Protego DF4 Lead Safety-Individual Adverse Event-Free Rate | Cardiac perforation | 0.06 percentage of participants |
| BIOTRONIK Protego DF4 Lead | Protego DF4 Lead Safety-Individual Adverse Event-Free Rate | Inability to extend helix | 0.06 percentage of participants |
| BIOTRONIK Protego DF4 Lead | Protego DF4 Lead Safety-Individual Adverse Event-Free Rate | Lead failure | 0.06 percentage of participants |
Secondary
Percentage of Subjects With no Adverse Events Excluded From Primary Objectives
The overall percentage of patients without adverse events that were excluded from the primary objectives and occurred through 5 years of follow-up. This was evaluated as an adverse event free-rate (AEFR).
Time frame: Up to 4.5 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BIOTRONIK Protego DF4 Lead | Percentage of Subjects With no Adverse Events Excluded From Primary Objectives | 90.73 percentage of participants |
Secondary
Protego DF4 Lead Pacing Impedance
Pacing impedance measurements for the Protego DF4 leads through 5 years of follow-up.
Time frame: Up to 4.5 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BIOTRONIK Protego DF4 Lead | Protego DF4 Lead Pacing Impedance | 552.3 Ohms | Standard Deviation 121.5 |
Secondary
Protego DF4 Lead Pacing Threshold Measurement
Pacing threshold measurements at pulse width of 0.4 or 0.5 ms for the Protego DF4 leads through 5 years of follow-up.
Time frame: Up to 4.5 years
Population: A threshold measurement for the Protego lead using a pulse width of 0.4 or 0.5 ms was unavailable for one subject. This patient was excluded from the analysis of this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BIOTRONIK Protego DF4 Lead | Protego DF4 Lead Pacing Threshold Measurement | 0.67 volts | Standard Deviation 0.36 |
Secondary
Protego DF4 Lead Sensing
Sensing measurements for the Protego DF4 leads through 5 years of follow-up.
Time frame: Up to 4.5 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BIOTRONIK Protego DF4 Lead | Protego DF4 Lead Sensing | 15.70 millivolts | Standard Deviation 5.97 |
Secondary
Protego DF4 Lead Shock Impedance
Shock impedance measurements for the Protego DF4 leads through 5 years of follow-up.
Time frame: Up to 4.5 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BIOTRONIK Protego DF4 Lead | Protego DF4 Lead Shock Impedance | 71.5 Ohms | Standard Deviation 13.4 |