The overall rate of serious Solia S Left Bundle Branch (LBB) lead related adverse device effects and serious implant procedure events related to the Solia S LBB lead that occur through 3 months post-implant. The definition of adverse device effect is an untoward medical occurrence (e.g. disease, injury) related to the use of a study device. Pacemaker lead-related examples include events such as lead dislodgements or lead malfunction. The Solia S LBB lead complication-free rate is calculated as the number of subjects without one or more adverse device effect complications divided by the total number of study subjects successfully enrolled and subjects undergoing an unsuccessful implant attempt who have a qualifying primary safety endpoint event. Classification of adverse device related events from the pool of potential events is determined by a clinical events committee (CEC). The complication-free rate is expressed in percent.

BIO-CONDUCT (NCT05251363) intent-to-treat subjects (having a successful or attempted Solia S implant in the LBBA) or subjects who had a qualifying primary safety endpoint event (such as a disease or injury related to the use of Solia S in the LBBA) prior to their exit from the study, were pooled with subjects in the BIO|MASTER.Selectra 3D study (NCT04323670) who satisfied the BIO-CONDUCT inclusion/exclusion criteria and experienced the primary endpoint or had at least 76 days of follow-up.

The percentage of subjects with Solia S placed successfully in the LBBA divided by the total number of consented study subjects in whom an implant of Solia S in the LBBA was attempted.

The population is defined as all enrolled subjects (subjects with successfully implanted Solia S in the LBBA) and subjects with an unsuccessful implant attempt of the Solia S in the LBBA. Determination of implant success is defined by the implanting physician at time of implant and includes assessments of the correct lead placement in the LBBA area during lead fixation. Final lead position is confirmed again after fixation.

The change in the physical function Short Form-36 (SF-36, 36-Item Short Form Health Survey) QOL subscale was calculated as the mean change from baseline to 12-month follow-up for all subjects that completed both the baseline QOL and 12-month QOL questionnaire. The physical function subscale of Short Form-36 is comprised of ten questions out of the total of 36 questions. The responses to the ten questions relating to physical function were averaged at baseline and at 12 months. The difference in the averages (12 months minus baseline) is reported as the outcome for secondary endpoint 1. Note that each question and each component is scored such that a higher score defines a more favorable health state. Each is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.

Population is defined as all enrolled subjects (subjects with successfully implanted Solia S in the LBBA) with evaluable, paired baseline and 12-mo measurements. Excludes subjects if baseline or 12-month QOL score cannot be calculated (due to missing or incomplete QOL data).

The overall rate of serious Solia S LBBA lead related adverse device effects and serious implant procedure events related to the Solia S LBBA lead that occur through 6 months post-implant. The Solia S LBBA lead complication-free rate per subject, which was calculated as the number of subjects without one or more complications divided by the total number of study subjects successfully enrolled and subjects undergoing an unsuccessful implant attempt who have a qualifying safety endpoint event. The complication-free rate is expressed in percentage of participants without SADE.

Descriptive analysis of BIO-CONDUCT (NCT05251363) intent-to-treat subjects (have a successfully implanted Solia S in the LBBA or had an unsuccessful implant attempt of Solia S in the LBBA) or subjects who had a qualifying primary safety endpoint event prior to their exit from the study were pooled with subjects in the BIO|MASTER.Selectra 3D study (NCT04323670) who satisfied the BIO-CONDUCT inclusion/exclusion criteria and experienced the primary endpoint or had at least 152 days of follow-up.

The overall rate of serious Solia S LBBA lead related adverse device effects and serious implant procedure events related to the Solia S LBBA lead that occur through 12 months post-implant. The Solia S LBBA lead complication-free rate per subject, which was calculated as the number of subjects without one or more complications divided by the total number of study subjects successfully enrolled and subjects undergoing an unsuccessful implant attempt who have a qualifying safety endpoint event. The complication-free rate is expressed in percent.

BIO-CONDUCT (NCT05251363) intent-to-treat subjects (have a successfully implanted Solia S in the LBBA or had an unsuccessful implant attempt of the Solia S in the LBBA) or subjects who had a qualifying primary safety endpoint event prior to their exit from the study were pooled with subjects in the BIO|MASTER.Selectra 3D study (NCT04323670) who satisfied the BIO-CONDUCT inclusion/exclusion criteria and experienced the primary endpoint or had at least 335 days of follow-up.

Pacing threshold measurements for Solia S leads implanted in the LBBA at the 3 month follow-up visit.

Includes Intent-to-Treat (ITT) subjects with valid threshold measurements at their 3-mo follow-up. Some leads may not have a value at a visit due to valid reasons, such as remote threshold information (capture control or automatic threshold measurement) is not available or thresholds not being performed at 0.4 ms, or due to source documentation being unavailable.

R-wave sensing amplitude measurements for Solia S leads implanted in the LBBA at the 3 month follow-up visit.

Includes Intent-to-Treat (ITT) subjects with valid R-wave sensed amplitude measurements at their 3-mo follow-up. Some leads may not have a value at a visit due to valid reasons, such as atrial fibrillation or complete heart block, or due to source documentation being unavailable.

Pacing impedance measurements for Solia S leads implanted in the LBBA at the 3 month follow-up visit.

Includes Intent-to-Treat (ITT) subjects with valid pacing impedance measurements at their 3-mo follow-up. Some leads may not have a value at a visit due to valid reasons such as remote due to source documentation being unavailable

Pacing threshold measurements for Solia S leads implanted in the LBBA at the 6 month follow-up visit.

Includes Intent-to-Treat (ITT) subjects with valid threshold measurements at their 6-mo follow-up. Some leads may not have a value at a visit due to valid reasons, such as remote threshold information (capture control or automatic threshold measurement) is not available or thresholds not being performed at 0.4 ms, or due to source documentation being unavailable.

R-wave sensing amplitude measurements for Solia S leads implanted in the LBBA at the 6 month follow-up visit.

Includes Intent-to-Treat (ITT) subjects with valid R-wave sensed amplitude measurements at their 6-mo follow-up. Some leads may not have a value at a visit due to valid reasons, such as atrial fibrillation or complete heart block, or due to source documentation being unavailable.

Pacing impedance measurements for Solia S leads implanted in the LBBA at the 6 month follow-up visit.

Includes Intent-to-Treat (ITT) subjects with valid pacing impedance measurements at their 6-mo follow-up. Some leads may not have a value at a visit due to valid reasons such as remote due to source documentation being unavailable.

Pacing threshold measurements for Solia S leads implanted in the LBBA at the 12 month follow-up visit.

Includes Intent-to-Treat (ITT) subjects with valid threshold measurements at their 12-mo follow-up. Some leads may not have a value at a visit due to valid reasons, such as remote threshold information (capture control or automatic threshold measurement) is not available or thresholds not being performed at 0.4 ms, or due to source documentation being unavailable.

R-wave sensing amplitude measurements for Solia S leads implanted in the LBBA at the 12 month follow-up visit.

Includes Intent-to-Treat (ITT) subjects with valid R-wave sensed amplitude measurements at their 12-mo follow-up. Some leads may not have a value at a visit due to valid reasons, such as atrial fibrillation or complete heart block, or due to source documentation being unavailable.

Pacing impedance measurements for Solia S leads implanted in the LBBA at the 12 month follow-up visit.

Includes Intent-to-Treat (ITT) subjects with valid pacing impedance measurements at their 12-mo follow-up. Some leads may not have a value at a visit due to valid reasons such as remote due to source documentation being unavailable.