Atrioventricular Block, Bradycardia, Cardiomyopathies, Left Bundle-Branch Block
Conditions
Brief summary
The purpose of the BIO-CONDUCT study is to demonstrate the safety and effectiveness of the BIOTRONIK Solia S pacing lead when implanted in the left bundle branch (LBB) area. Safety will be assessed by evaluating serious adverse device effects that occur through 3 months post-implant. Efficacy will be assessed by evaluating implant success rate.
Interventions
DEVICESolia S lead
The Solia S pacing lead will be implanted in the LBB area for patients who meet all inclusion/exclusion criteria and give written informed consent.
Sponsors
Biotronik, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient is a candidate for implantation of a BIOTRONIK pacemaker system, per standard guidelines. Single chamber, dual chamber, and Cardiac Resynchronization Therapy with a Pacemaker (CRT-P) systems are allowed. * Patient has an implant planned to utilize left bundle branch area pacing within 30 days of consent * Patient is able to understand the nature of the study and provide written informed consent * Patient is available for follow-up visits on a regular basis for the expected duration of follow-up * Patient accepts Home Monitoring® concept * Patient age is greater than or equal to 18 years at time of consent
Exclusion criteria
* Patient meets a standard contraindication for pacemaker system implant * Patient is currently implanted with a pacemaker or Implantable Cardioverter-Defibrillator (ICD) device * Patient has had a previous unsuccessful attempt to place a lead in the LBB area * Patient has planned cardiac surgical procedures or interventional measures within 3 months after implant * Patient is expected to receive a heart transplant within 12 months * Patient life expectancy less than 12 months * Patient has the presence of another life-threatening, underlying illness separate from their cardiac disorder * Patient reports pregnancy at the time of enrollment * Patient is enrolled in any other investigational cardiac clinical study during the course of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serious Adverse Device Effect (SADE)-Free Rate at 3 Months | 3 months post implant | 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. |
| Implant Success Rate of the Solia S Lead in LBB Area | at implant procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serious Adverse Device Effect (SADE)-Free Rate at 12 Months | 12 months post implant | 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. |
| Pacing Threshold Measurements for Solia S Lead at 3 Months | 3 months post implant | Pacing threshold measurements for Solia S leads implanted in the LBBA at the 3 month follow-up visit. |
| Sensing Measurements for Solia S Lead at 3 Months | 3 months post implant | R-wave sensing amplitude measurements for Solia S leads implanted in the LBBA at the 3 month follow-up visit. |
| Pacing Impedance for Solia S Lead at 3 Months | 3 months post implant | Pacing impedance measurements for Solia S leads implanted in the LBBA at the 3 month follow-up visit. |
| Pacing Threshold Measurements for Solia S Lead at 6 Months | 6 months post implant | Pacing threshold measurements for Solia S leads implanted in the LBBA at the 6 month follow-up visit. |
| Quality of Life (QOL) From Baseline Through 12 Months Post-Implant | 12 months post implant | 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. |
| Pacing Impedance for Solia S Lead at 6 Months | 6 months post implant | Pacing impedance measurements for Solia S leads implanted in the LBBA at the 6 month follow-up visit. |
| Pacing Threshold Measurements for Solia S Lead at 12 Months | 12 months post implant | Pacing threshold measurements for Solia S leads implanted in the LBBA at the 12 month follow-up visit. |
| Sensing Measurements for Solia S Lead at 12 Months | 12 months post implant | R-wave sensing amplitude measurements for Solia S leads implanted in the LBBA at the 12 month follow-up visit. |
| Pacing Impedance for Solia S Lead at 12 Months | 12 months post implant | Pacing impedance measurements for Solia S leads implanted in the LBBA at the 12 month follow-up visit. |
| Sensing Measurements for Solia S Lead at 6 Months | 6 months post implant | R-wave sensing amplitude measurements for Solia S leads implanted in the LBBA at the 6 month follow-up visit. |
| Serious Adverse Device Effect (SADE)-Free Rate at 6 Months | 6 months post implant | 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. |
Countries
United States
Participant flow
Recruitment details
The first study subject was consented on December 12, 2022. Study enrollment was completed on September 22, 2023, with a total of 194 subjects consented at 14 sites.
Pre-assignment details
Of the 194 enrolled participants, 186 met inclusion criteria and underwent an implant procedure attempt.
Participants by arm
| Arm | Count |
|---|---|
| Subjects With a Successful Solia S Implant in the LBBA This includes subjects that were consented and had a successful Solia S LBBA lead implant according to the study implant success criteria. | 178 |
| Total | 178 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Implant | Subject did not meet LBBA implant criteria | 8 |
| Overall Study After Implant Period | Death | 9 |
| Overall Study After Implant Period | Lost to Follow-up | 2 |
| Overall Study After Implant Period | Physician Decision | 1 |
| Overall Study After Implant Period | Solia S lead in LBBA Position Extracted | 4 |
| Overall Study After Implant Period | Subject Moved from Investigational Center | 3 |
| Overall Study After Implant Period | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Subjects With a Successful Solia S Implant in the LBBA |
|---|---|
| Age, Continuous | 76.2 Years STANDARD_DEVIATION 9.12 |
| BMI | 28.8 kg/m² STANDARD_DEVIATION 5.43 |
| Cardiac Medication at Implant ACE Inhibitors | 36 Participants |
| Cardiac Medication at Implant Aldosterone Antagonist | 6 Participants |
| Cardiac Medication at Implant Angiotensin Receptor Blocker | 51 Participants |
| Cardiac Medication at Implant Angiotensin Receptor-Neprilisyn Inhibitor | 2 Participants |
| Cardiac Medication at Implant Anticoagulant | 68 Participants |
| Cardiac Medication at Implant Antiplatelet | 57 Participants |
| Cardiac Medication at Implant Class I Antiarrhythmic/Sodium-channel Blocker | 9 Participants |
| Cardiac Medication at Implant Class II Antiarrhythmic/Beta Blocker | 55 Participants |
| Cardiac Medication at Implant Class III Antiarrhythmic/Potassium-channel Blocker | 15 Participants |
| Cardiac Medication at Implant Class IV Antiarrhythmic/Calcium Channel Blocker | 40 Participants |
| Cardiac Medication at Implant Digitalis | 2 Participants |
| Cardiac Medication at Implant Diuretics Other Than Aldosterone Antagonist | 60 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 156 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 14 Participants |
| Height | 67.4 Inches STANDARD_DEVIATION 4.23 |
| Implant Indication Atrioventricular (AV) Block | 70 Participants |
| Implant Indication Other | 11 Participants |
| Implant Indication Planned or Prior AV Node Ablation | 9 Participants |
| Implant Indication Primary Heart Failure Indication | 1 Participants |
| Implant Indication Sinus Node Disease/Sick Sinus Syndrome | 87 Participants |
| Medical History Atrial Fibrillation | 81 Participants |
| Medical History Cardiomyopathy | 13 Participants |
| Medical History Cerebrovascular Disease (e.g., TIA / Stroke) | 33 Participants |
| Medical History Chronic Kidney Disease (CKD) | 44 Participants |
| Medical History Chronic Obstructive Pulmonary Disease | 23 Participants |
| Medical History Coronary Artery Disease | 61 Participants |
| Medical History Diabetes Mellitus | 41 Participants |
| Medical History Heart Failure | 44 Participants |
| Medical History Hypertension | 152 Participants |
| Medical History Peripheral Artery Disease | 16 Participants |
| Medical History Prior Myocardial Infarction | 22 Participants |
| Medical History Sleep Apnea | 47 Participants |
| Medical History Valvular Heart Disease | 46 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 17 Participants |
| Race (NIH/OMB) White | 142 Participants |
| Sex: Female, Male Female | 65 Participants |
| Sex: Female, Male Male | 113 Participants |
| Weight | 186.3 Pounds STANDARD_DEVIATION 41.66 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 9 / 186 |
| other Total, other adverse events | 0 / 186 |
| serious Total, serious adverse events | 52 / 186 |
Outcome results
Primary
Implant Success Rate of the Solia S Lead in LBB Area
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.
Time frame: at implant procedure
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intent-to-treat (ITT) - Primary Endpoint 1 | Implant Success Rate of the Solia S Lead in LBB Area | 95.7 % of participants with implant success |
Comparison: H0: Implant Success Rate ≤ 80% Ha: Implant Success Rate \> 80% Used an exact binomial test comparing the observed proportion (implant success rate) to the performance goal of 80%. The lower, two-sided 95% confidence bound for the overall implant success rate must be greater than 80% to reject the null hypothesis (Ho), which would demonstrate evidence that the rate of successful Solia S LBBA implants is significantly higher than 80.0%.p-value: <0.0001Exact binomial test
Primary
Serious Adverse Device Effect (SADE)-Free Rate at 3 Months
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.
Time frame: 3 months post implant
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intent-to-treat (ITT) - Primary Endpoint 1 | Serious Adverse Device Effect (SADE)-Free Rate at 3 Months | 98 Percentage of participants without SADE |
Comparison: Ho: SADE-free rate ≤ 87.5% Ha: SADE-free rate \> 87.5% Used an exact binomial test comparing the observed proportion (overall SADE-free rate through 3 months) to the performance goal of 87.5%. The lower, two-sided 95% confidence bound for the overall SADE-free rate must be greater than 87.5% to reject the null hypothesis (Ho), which would demonstrate evidence that the SADE-free rate is significantly higher than 87.5%.p-value: <0.0001Exact binomial test
Secondary
Pacing Impedance for Solia S Lead at 12 Months
Pacing impedance measurements for Solia S leads implanted in the LBBA at the 12 month follow-up visit.
Time frame: 12 months post implant
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intent-to-treat (ITT) - Primary Endpoint 1 | Pacing Impedance for Solia S Lead at 12 Months | 521.8 Impedance (Ω) | Standard Deviation 96.6 |
Secondary
Pacing Impedance for Solia S Lead at 3 Months
Pacing impedance measurements for Solia S leads implanted in the LBBA at the 3 month follow-up visit.
Time frame: 3 months post implant
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intent-to-treat (ITT) - Primary Endpoint 1 | Pacing Impedance for Solia S Lead at 3 Months | 540.4 Impedance (Ω) | Standard Deviation 96.4 |
Secondary
Pacing Impedance for Solia S Lead at 6 Months
Pacing impedance measurements for Solia S leads implanted in the LBBA at the 6 month follow-up visit.
Time frame: 6 months post implant
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intent-to-treat (ITT) - Primary Endpoint 1 | Pacing Impedance for Solia S Lead at 6 Months | 526.7 Impedance (Ω) | Standard Deviation 96.7 |
Secondary
Pacing Threshold Measurements for Solia S Lead at 12 Months
Pacing threshold measurements for Solia S leads implanted in the LBBA at the 12 month follow-up visit.
Time frame: 12 months post implant
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intent-to-treat (ITT) - Primary Endpoint 1 | Pacing Threshold Measurements for Solia S Lead at 12 Months | 0.98 Volts @ 0.4ms | Standard Deviation 0.29 |
Secondary
Pacing Threshold Measurements for Solia S Lead at 3 Months
Pacing threshold measurements for Solia S leads implanted in the LBBA at the 3 month follow-up visit.
Time frame: 3 months post implant
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intent-to-treat (ITT) - Primary Endpoint 1 | Pacing Threshold Measurements for Solia S Lead at 3 Months | 0.94 Volts @ 0.4ms | Standard Deviation 0.26 |
Secondary
Pacing Threshold Measurements for Solia S Lead at 6 Months
Pacing threshold measurements for Solia S leads implanted in the LBBA at the 6 month follow-up visit.
Time frame: 6 months post implant
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intent-to-treat (ITT) - Primary Endpoint 1 | Pacing Threshold Measurements for Solia S Lead at 6 Months | 0.97 Volts @ 0.4ms | Standard Deviation 0.27 |
Secondary
Quality of Life (QOL) From Baseline Through 12 Months Post-Implant
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.
Time frame: 12 months post implant
Population: 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).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intent-to-treat (ITT) - Primary Endpoint 1 | Quality of Life (QOL) From Baseline Through 12 Months Post-Implant | 11.4 Score on a Scale |
Comparison: H0: Improvement in QOL Physical Function Scale ≤ 2.8 Ha: Improvement in QOL Physical Function Scale \> 2.8 Exact one-sample t-test comparing mean improvement in QOL from baseline to 12-mo post-implant to a goal of +2.8. The lower, two-sided 95% confidence bound for the improvement in QOL must be \> +2.8 to reject H0.p-value: <0.001t-test, 2 sided
Secondary
Sensing Measurements for Solia S Lead at 12 Months
R-wave sensing amplitude measurements for Solia S leads implanted in the LBBA at the 12 month follow-up visit.
Time frame: 12 months post implant
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intent-to-treat (ITT) - Primary Endpoint 1 | Sensing Measurements for Solia S Lead at 12 Months | 12.76 mV | Standard Deviation 4.83 |
Secondary
Sensing Measurements for Solia S Lead at 3 Months
R-wave sensing amplitude measurements for Solia S leads implanted in the LBBA at the 3 month follow-up visit.
Time frame: 3 months post implant
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intent-to-treat (ITT) - Primary Endpoint 1 | Sensing Measurements for Solia S Lead at 3 Months | 12.37 mV | Standard Deviation 4.16 |
Secondary
Sensing Measurements for Solia S Lead at 6 Months
R-wave sensing amplitude measurements for Solia S leads implanted in the LBBA at the 6 month follow-up visit.
Time frame: 6 months post implant
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intent-to-treat (ITT) - Primary Endpoint 1 | Sensing Measurements for Solia S Lead at 6 Months | 12.83 mV | Standard Deviation 4.78 |
Secondary
Serious Adverse Device Effect (SADE)-Free Rate at 12 Months
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.
Time frame: 12 months post implant
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intent-to-treat (ITT) - Primary Endpoint 1 | Serious Adverse Device Effect (SADE)-Free Rate at 12 Months | 96.1 Percentage of participants without SADE |
Secondary
Serious Adverse Device Effect (SADE)-Free Rate at 6 Months
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.
Time frame: 6 months post implant
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intent-to-treat (ITT) - Primary Endpoint 1 | Serious Adverse Device Effect (SADE)-Free Rate at 6 Months | 96.7 Percentage of participants without SADE |