Safety and Effectiveness of the Siello S Lead
Conditions
Brief summary
The objective of the SIELLO study is to demonstrate the safety and effectiveness of the BIOTRONIK Siello S pacing lead.
Interventions
DEVICEmarket-released BIOTRONIK pacemaker system including one or two Siello S leads.
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
* Candidate for de novo implantation of a BIOTRONIK pacemaker system, including one or two Siello S leads. Candidate meets recommendation for pacemaker system implant put forth by guidelines of relevant professional societies. * Able to understand the nature of the study 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 other investigational clinical study. * Currently implanted with a pacemaker or ICD device. * Planned cardiac surgical procedures or interventional measures within the next 6 months. * Expected to receive a heart transplant within 1 year. * Life expectancy less than 1 year. * Presence of another life-threatening, underlying illness separate from their cardiac disorder. * Pregnant at the time of enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Atrial Siello S Lead Safety at 12 Months | 12 month | The overall percentage subjects with adverse events that require additional invasive intervention to resolve, related to the Siello leads implanted in the atrium with a BIOTRONIK Evia pacemaker device through 12 months follow-up. This was evaluated as an adverse event free-rate (AEFR). |
| Ventricular Siello S Lead Safety at 12 Months | 12-month | The overall percentage of subjects with adverse events that require additional invasive intervention to resolve, related to the Siello leads implanted in the ventricle with a BIOTRONIK Evia pacemaker device through 12 months follow-up. This was evaluated as an adverse event free-rate (AEFR). |
| Siello S Lead Effectiveness at 12 Months | 12-months | Success rate of the implanted system to sense and deliver pacing at 12-months post implant. |
| Ventricular Siello S Lead Safety at 5 Years | 5-Years | The overall percentage of subjects with adverse events that require additional invasive intervention to resolve, related to the Siello leads implanted in the ventricle with a BIOTRONIK Evia pacemaker device through 5 years follow-up. This was evaluated as an adverse event free-rate (AEFR). |
| Ventricular Siello S Lead Safety at 5 Years - Individual Adverse Event Rates | 5-years | Evaluation of the individual adverse events contributing to the outcome measure 'Ventricular Siello S Lead Safety at 5 Years'. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Other Adverse Events | 5-years | The overall percentage of subjects with reportable adverse events that were excluded from primary and secondary objectives and occurred through 5 years of follow-up. This was evaluated as an adverse event free-rate (AEFR). Adverse events were considered reportable if the event was related to the implant procedure, implanted pulse generator, or implanted leads. |
| Siello S Lead Effectiveness at 5 Years | 5-years | Success rate of the implanted system to deliver long-term pacing at 5-years post-implant. |
| Atrial Siello S Lead Safety at 5 Years | 5-years | The overall percentage of subjects with adverse events that require additional invasive intervention to resolve, related to the Siello leads implanted in the atrium with a BIOTRONIK Evia pacemaker device through 5 years follow-up. This was evaluated as an adverse event free-rate (AEFR). |
| Sensing Measurements for Siello S Leads Through 5 Years | 5-years | Sensing measurements for Siello S leads implanted in the atrium or ventricle through the 5 year follow-up visit. |
| Impedance Measurements for Siello S Leads Through 5 Years | 5-years | Impedance measurements for Siello S leads implanted in the atrium or ventricle through the 5 year follow-up visit. |
| Pacing Threshold Measurements for Siello S Leads Through 5 Years | 5-years | Pacing threshold measurements for Siello S leads implanted in the atrium or ventricle through 5 years of follow-up. |
| Atrial Siello S Lead Safety at 5 Years - Individual Adverse Event Rates | 5-years | Evaluation of the individual adverse events contributing to the outcome measure 'Atrial Siello S Lead Safety at 5 Years'. |
| Pacing Threshold Measurements for Siello S Leads at 12 Months | 12-months | Pacing threshold measurements for Siello S leads implanted in the atrium or ventricle at the 12 month follow-up visit. |
| Sensing Measurements for Siello S Leads at 12 Months | 12-months | Sensing measurements for Siello S leads implanted in the atrium or ventricle at the 12 month follow-up visit. |
| Impedance Measurements for Siello S Leads at 12 Months | 12-months | Impedance measurements for Siello S leads implanted in the atrium or ventricle at the 12 month follow-up visit. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BIOTRONIK Siello S Lead Patients with a BIOTRONIK pacemaker system including one or two Siello S leads. | 1,758 |
| Total | 1,758 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | All Siello leads are explanted | 31 |
| Overall Study | Completion of 30 day safety registry | 1 |
| Overall Study | Death | 356 |
| Overall Study | Lost to Follow-up | 42 |
| Overall Study | Patient has withdrawn from study | 293 |
| Overall Study | Study terminated for EP Passion | 749 |
Baseline characteristics
| Characteristic | BIOTRONIK Siello S Lead |
|---|---|
| Age, Continuous | 74.4 years STANDARD_DEVIATION 10.9 |
| Height | 66.9 inches STANDARD_DEVIATION 4.3 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 2 Participants |
| Race/Ethnicity, Customized Asian | 22 Participants |
| Race/Ethnicity, Customized Black or African American | 112 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 47 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 2 Participants |
| Race/Ethnicity, Customized Not Reported | 193 Participants |
| Race/Ethnicity, Customized White | 1380 Participants |
| Region of Enrollment United States | 1758 participants |
| Sex: Female, Male Female | 821 Participants |
| Sex: Female, Male Male | 937 Participants |
| Weight | 187.8 pounds STANDARD_DEVIATION 51.6 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 356 / 1,758 |
| other Total, other adverse events | 154 / 1,758 |
| serious Total, serious adverse events | 145 / 1,758 |
Outcome results
Primary
Atrial Siello S Lead Safety at 12 Months
The overall percentage subjects with adverse events that require additional invasive intervention to resolve, related to the Siello leads implanted in the atrium with a BIOTRONIK Evia pacemaker device through 12 months follow-up. This was evaluated as an adverse event free-rate (AEFR).
Time frame: 12 month
Population: The Pre-Market cohort was defined as the population of subjects who were implanted (or had an implant attempt) of an atrial Siello lead on or before the implant date of the last subject to reach the 12-month follow-up time point as of April 3, 2015 and/or experienced a qualifying event.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BIOTRONIK Siello S Atrial Lead | Atrial Siello S Lead Safety at 12 Months | 100 percentage of participants |
p-value: <0.0001Exact, binomial
Primary
Siello S Lead Effectiveness at 12 Months
Success rate of the implanted system to sense and deliver pacing at 12-months post implant.
Time frame: 12-months
Population: The Pre-Market cohort was defined as the population of subjects who were implanted (or had an implant attempt) of one or more Siello leads on or before the implant date of the last subject to reach the 12-month follow-up time point as of April 3, 2015 and/or experienced a qualifying event.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BIOTRONIK Siello S Atrial Lead | Siello S Lead Effectiveness at 12 Months | 100 percentage of participants |
Comparison: The primary endpoint 3 hypothesis was evaluated by performing an exact, binomial test comparing a binomial proportion (successful sensing and pacing rate at 12 months) to 97.0%, with Type I error (alpha) or 0.025 and power of 80%.p-value: <0.0001Exact, binomial
Primary
Ventricular Siello S Lead Safety at 12 Months
The overall percentage of subjects with adverse events that require additional invasive intervention to resolve, related to the Siello leads implanted in the ventricle with a BIOTRONIK Evia pacemaker device through 12 months follow-up. This was evaluated as an adverse event free-rate (AEFR).
Time frame: 12-month
Population: The Pre-Market cohort was defined as the population of subjects who were implanted (or had an implant attempt) of a ventricular Siello lead on or before the implant date of the last subject to reach the 12-month follow-up time point as of April 3, 2015 and/or experienced a qualifying event.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BIOTRONIK Siello S Atrial Lead | Ventricular Siello S Lead Safety at 12 Months | 99.62 percentage of participants |
Comparison: The primary endpoint 2 hypothesis was evaluated by performing an exact, binomial test comparing a binomial proportion (AEFR at 12 months) to 94.0%, with Type I error (alpha) or 0.025 and power of 80%.p-value: <0.0001Exact, binomial
Primary
Ventricular Siello S Lead Safety at 5 Years
The overall percentage of subjects with adverse events that require additional invasive intervention to resolve, related to the Siello leads implanted in the ventricle with a BIOTRONIK Evia pacemaker device through 5 years follow-up. This was evaluated as an adverse event free-rate (AEFR).
Time frame: 5-Years
Population: The Post-Market cohort included all patient who were enrolled in the study and had a Siello lead implanted in the right ventricular position.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BIOTRONIK Siello S Atrial Lead | Ventricular Siello S Lead Safety at 5 Years | 99.71 percentage of participants |
Comparison: The primary endpoint 4 hypothesis was evaluated by performing an exact, binomial test comparing a binomial proportion (AEFR at 5 years) to 92.5%, with Type I error (alpha) or 0.025 and power of 80%.
Primary
Ventricular Siello S Lead Safety at 5 Years - Individual Adverse Event Rates
Evaluation of the individual adverse events contributing to the outcome measure 'Ventricular Siello S Lead Safety at 5 Years'.
Time frame: 5-years
Population: The Post-Market cohort included all patient who were enrolled in the study and had a Siello lead implanted in the right ventricular position.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BIOTRONIK Siello S Atrial Lead | Ventricular Siello S Lead Safety at 5 Years - Individual Adverse Event Rates | Lead impedance out of range, High | 0.17 percentage of participants |
| BIOTRONIK Siello S Atrial Lead | Ventricular Siello S Lead Safety at 5 Years - Individual Adverse Event Rates | Lead conductor fracture | 0.12 percentage of participants |
Secondary
Atrial Siello S Lead Safety at 5 Years
The overall percentage of subjects with adverse events that require additional invasive intervention to resolve, related to the Siello leads implanted in the atrium with a BIOTRONIK Evia pacemaker device through 5 years follow-up. This was evaluated as an adverse event free-rate (AEFR).
Time frame: 5-years
Population: The Post-Market cohort included all patient who were enrolled in the study and had a Siello lead implanted in the right atrial position.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BIOTRONIK Siello S Atrial Lead | Atrial Siello S Lead Safety at 5 Years | 99.87 percentage of participants |
Secondary
Atrial Siello S Lead Safety at 5 Years - Individual Adverse Event Rates
Evaluation of the individual adverse events contributing to the outcome measure 'Atrial Siello S Lead Safety at 5 Years'.
Time frame: 5-years
Population: On April 15, 2019, BIOTRONIK received FDA approval to transition the ongoing SIELLO Post Approval Registry to a new EP PASSION real-world data methodology. Therefore, this outcome measure was not completed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BIOTRONIK Siello S Atrial Lead | Atrial Siello S Lead Safety at 5 Years - Individual Adverse Event Rates | Intermittent capture | 0.07 percentage of participants |
| BIOTRONIK Siello S Atrial Lead | Atrial Siello S Lead Safety at 5 Years - Individual Adverse Event Rates | Suspected lead failure | 0.07 percentage of participants |
Secondary
Impedance Measurements for Siello S Leads at 12 Months
Impedance measurements for Siello S leads implanted in the atrium or ventricle at the 12 month follow-up visit.
Time frame: 12-months
Population: All originally implanted ventricular or atrial Siello leads with 12-month follow-up data entered into the EDC on or before April 3, 2015 are included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BIOTRONIK Siello S Atrial Lead | Impedance Measurements for Siello S Leads at 12 Months | 595.7 Ohms | Standard Deviation 89.1 |
| Siello S Atrial Leads | Impedance Measurements for Siello S Leads at 12 Months | 524.0 Ohms | Standard Deviation 66.7 |
Secondary
Impedance Measurements for Siello S Leads Through 5 Years
Impedance measurements for Siello S leads implanted in the atrium or ventricle through the 5 year follow-up visit.
Time frame: 5-years
Population: All originally implanted ventricular or atrial Siello leads with implant and follow-up data entered into the EDC on or before April 17, 2019 are included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BIOTRONIK Siello S Atrial Lead | Impedance Measurements for Siello S Leads Through 5 Years | 597.6 Ohms | Standard Deviation 100 |
| Siello S Atrial Leads | Impedance Measurements for Siello S Leads Through 5 Years | 514.4 Ohms | Standard Deviation 72.6 |
Secondary
Pacing Threshold Measurements for Siello S Leads at 12 Months
Pacing threshold measurements for Siello S leads implanted in the atrium or ventricle at the 12 month follow-up visit.
Time frame: 12-months
Population: All originally implanted ventricular or atrial Siello leads with 12-month follow-up data entered into the EDC on or before April 3, 2015 are included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BIOTRONIK Siello S Atrial Lead | Pacing Threshold Measurements for Siello S Leads at 12 Months | 0.86 volts | Standard Deviation 0.29 |
| Siello S Atrial Leads | Pacing Threshold Measurements for Siello S Leads at 12 Months | 0.85 volts | Standard Deviation 0.35 |
Secondary
Pacing Threshold Measurements for Siello S Leads Through 5 Years
Pacing threshold measurements for Siello S leads implanted in the atrium or ventricle through 5 years of follow-up.
Time frame: 5-years
Population: All originally implanted ventricular or atrial Siello leads with implant and follow-up data entered into the EDC on or before April 17, 2019 are included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BIOTRONIK Siello S Atrial Lead | Pacing Threshold Measurements for Siello S Leads Through 5 Years | 0.84 volts | Standard Deviation 0.34 |
| Siello S Atrial Leads | Pacing Threshold Measurements for Siello S Leads Through 5 Years | 0.83 volts | Standard Deviation 0.34 |
Secondary
Percentage of Participants With Other Adverse Events
The overall percentage of subjects with reportable adverse events that were excluded from primary and secondary objectives and occurred through 5 years of follow-up. This was evaluated as an adverse event free-rate (AEFR). Adverse events were considered reportable if the event was related to the implant procedure, implanted pulse generator, or implanted leads.
Time frame: 5-years
Population: The Post-Market cohort included all patient who were enrolled in the study and had one or two Siello leads implanted.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BIOTRONIK Siello S Atrial Lead | Percentage of Participants With Other Adverse Events | 84.02 percentage of participants |
Secondary
Sensing Measurements for Siello S Leads at 12 Months
Sensing measurements for Siello S leads implanted in the atrium or ventricle at the 12 month follow-up visit.
Time frame: 12-months
Population: All originally implanted ventricular or atrial Siello leads with 12-month follow-up data entered into the EDC on or before April 3, 2015 are included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BIOTRONIK Siello S Atrial Lead | Sensing Measurements for Siello S Leads at 12 Months | 12.68 mV | Standard Deviation 5.02 |
| Siello S Atrial Leads | Sensing Measurements for Siello S Leads at 12 Months | 3.66 mV | Standard Deviation 1.92 |
Secondary
Sensing Measurements for Siello S Leads Through 5 Years
Sensing measurements for Siello S leads implanted in the atrium or ventricle through the 5 year follow-up visit.
Time frame: 5-years
Population: All originally implanted ventricular or atrial Siello leads with implant and follow-up data entered into the EDC on or before April 17, 2019 are included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BIOTRONIK Siello S Atrial Lead | Sensing Measurements for Siello S Leads Through 5 Years | 12.17 mV | Standard Deviation 4.6 |
| Siello S Atrial Leads | Sensing Measurements for Siello S Leads Through 5 Years | 3.53 mV | Standard Deviation 1.95 |
Secondary
Siello S Lead Effectiveness at 5 Years
Success rate of the implanted system to deliver long-term pacing at 5-years post-implant.
Time frame: 5-years
Population: The Post-Market cohort included all patient who were enrolled in the study and had one or two Siello leads implanted.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BIOTRONIK Siello S Atrial Lead | Siello S Lead Effectiveness at 5 Years | 99.94 percentage of participants |