Safety and Performance Study of the Siello S Pacing Lead

Study Overview
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Brief Summary
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The objective of the SIELLO study is to demonstrate the safety and effectiveness of the BIOTRONIK Siello S pacing lead.

Conditions
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Safety and Effectiveness of the Siello S Lead

Intervention / Treatment
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* Device: market-released BIOTRONIK pacemaker system including one or two Siello S leads.


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pacemaker Therapy<br>Patients with a market-released BIOTRONIK pacemaker system including one or two Siello S leads. | Device: market-released BIOTRONIK pacemaker system including one or two Siello S leads.<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 12 month | 
| 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). | 12-month | 
| Siello S Lead Effectiveness at 12 Months | Success rate of the implanted system to sense and deliver pacing at 12-months post implant. | 12-months | 
| 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). | 5-Years | 
| 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'. | 5-years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 5-years | 
| 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'. | 5-years | 
| 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. | 12-months | 
| 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. | 12-months | 
| 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. | 12-months | 
| 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. | 5-years | 
| Siello S Lead Effectiveness at 5 Years | Success rate of the implanted system to deliver long-term pacing at 5-years post-implant. | 5-years | 
| 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. | 5-years | 
| 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. | 5-years | 
| 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. | 5-years |