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).

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.

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).

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.

Success rate of the implanted system to sense and deliver pacing at 12-months post implant.

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.

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).

The Post-Market cohort included all patient who were enrolled in the study and had a Siello lead implanted in the right ventricular position.

Evaluation of the individual adverse events contributing to the outcome measure 'Ventricular Siello S Lead Safety at 5 Years'.

The Post-Market cohort included all patient who were enrolled in the study and had a Siello lead implanted in the right ventricular position.

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).

The Post-Market cohort included all patient who were enrolled in the study and had a Siello lead implanted in the right atrial position.

Evaluation of the individual adverse events contributing to the outcome measure 'Atrial Siello S Lead Safety at 5 Years'.

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.

Pacing threshold measurements for Siello S leads implanted in the atrium or ventricle at the 12 month follow-up visit.

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.

Sensing measurements for Siello S leads implanted in the atrium or ventricle at the 12 month follow-up visit.

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.

Impedance measurements for Siello S leads implanted in the atrium or ventricle at the 12 month follow-up visit.

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.

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.

The Post-Market cohort included all patient who were enrolled in the study and had one or two Siello leads implanted.

Success rate of the implanted system to deliver long-term pacing at 5-years post-implant.

The Post-Market cohort included all patient who were enrolled in the study and had one or two Siello leads implanted.

Pacing threshold measurements for Siello S leads implanted in the atrium or ventricle through 5 years of follow-up.

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.

Sensing measurements for Siello S leads implanted in the atrium or ventricle through the 5 year follow-up visit.

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.

Impedance measurements for Siello S leads implanted in the atrium or ventricle through the 5 year follow-up visit.

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.