Trial Outcomes & Findings for BIOTRONIK Conduction System Pacing With the Solia Lead (NCT NCT05251363)

Last Updated: 2025-03-18

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

194 participants

Primary outcome timeframe

3 months post implant

Results posted on

2025-03-18

Participant Flow

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.

Of the 194 enrolled participants, 186 met inclusion criteria and underwent an implant procedure attempt.

Participant milestones

Participant milestones
Measure	Solia S LBB Lead Solia S lead: The Solia S pacing lead will be implanted in the LBBA for patients who meet all inclusion/exclusion criteria and give written informed consent.
Implant STARTED	186
Implant COMPLETED	178
Implant NOT COMPLETED	8
Overall Study After Implant Period STARTED	178
Overall Study After Implant Period Protocol Follow-Up: 3-Month	167
Overall Study After Implant Period Protocol Follow-Up: 6-Month	163
Overall Study After Implant Period Protocol Follow-Up (Final): 12-Month	155
Overall Study After Implant Period COMPLETED	155
Overall Study After Implant Period NOT COMPLETED	23

Reasons for withdrawal

Reasons for withdrawal
Measure	Solia S LBB Lead Solia S lead: The Solia S pacing lead will be implanted in the LBBA for patients who meet all inclusion/exclusion criteria and give written informed consent.
Implant Subject did not meet LBBA implant criteria	8
Overall Study After Implant Period Death	9
Overall Study After Implant Period Solia S lead in LBBA Position Extracted	4
Overall Study After Implant Period Withdrawal by Subject	4
Overall Study After Implant Period Lost to Follow-up	2
Overall Study After Implant Period Physician Decision	1
Overall Study After Implant Period Subject Moved from Investigational Center	3

Baseline Characteristics

Height data was provided by only 175 subjects.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Subjects With a Successful Solia S Implant in the LBBA n=178 Participants This includes subjects that were consented and had a successful Solia S LBBA lead implant according to the study implant success criteria.
Medical History Cerebrovascular Disease (e.g., TIA / Stroke)	33 Participants n=178 Participants
Medical History Chronic Kidney Disease (CKD)	44 Participants n=178 Participants
Medical History Valvular Heart Disease	46 Participants n=178 Participants
Medical History Peripheral Artery Disease	16 Participants n=178 Participants
Cardiac Medication at Implant ACE Inhibitors	36 Participants n=178 Participants
Cardiac Medication at Implant Angiotensin Receptor Blocker	51 Participants n=178 Participants
Cardiac Medication at Implant Angiotensin Receptor-Neprilisyn Inhibitor	2 Participants n=178 Participants
Cardiac Medication at Implant Class I Antiarrhythmic/Sodium-channel Blocker	9 Participants n=178 Participants
Cardiac Medication at Implant Class II Antiarrhythmic/Beta Blocker	55 Participants n=178 Participants
Cardiac Medication at Implant Class III Antiarrhythmic/Potassium-channel Blocker	15 Participants n=178 Participants
Cardiac Medication at Implant Class IV Antiarrhythmic/Calcium Channel Blocker	40 Participants n=178 Participants
Cardiac Medication at Implant Digitalis	2 Participants n=178 Participants
Cardiac Medication at Implant Anticoagulant	68 Participants n=178 Participants
Cardiac Medication at Implant Antiplatelet	57 Participants n=178 Participants
Cardiac Medication at Implant Aldosterone Antagonist	6 Participants n=178 Participants
Cardiac Medication at Implant Diuretics Other Than Aldosterone Antagonist	60 Participants n=178 Participants
Implant Indication Sinus Node Disease/Sick Sinus Syndrome	87 Participants n=178 Participants
Implant Indication Atrioventricular (AV) Block	70 Participants n=178 Participants
Implant Indication Planned or Prior AV Node Ablation	9 Participants n=178 Participants
Implant Indication Primary Heart Failure Indication	1 Participants n=178 Participants
Implant Indication Other	11 Participants n=178 Participants
Age, Continuous	76.2 Years STANDARD_DEVIATION 9.12 • n=178 Participants
Sex: Female, Male Female	65 Participants n=178 Participants
Sex: Female, Male Male	113 Participants n=178 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=178 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	156 Participants n=178 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	14 Participants n=178 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=178 Participants
Race (NIH/OMB) Asian	2 Participants n=178 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=178 Participants
Race (NIH/OMB) Black or African American	15 Participants n=178 Participants
Race (NIH/OMB) White	142 Participants n=178 Participants
Race (NIH/OMB) More than one race	1 Participants n=178 Participants
Race (NIH/OMB) Unknown or Not Reported	17 Participants n=178 Participants
Height	67.4 Inches STANDARD_DEVIATION 4.23 • n=175 Participants • Height data was provided by only 175 subjects.
Weight	186.3 Pounds STANDARD_DEVIATION 41.66 • n=176 Participants • Weight data was provided by only 176 subjects.
BMI	28.8 kg/m² STANDARD_DEVIATION 5.43 • n=175 Participants • Height data (a component of BMI calculation), was provided by only 175 subjects.
Medical History Heart Failure	44 Participants n=178 Participants
Medical History Cardiomyopathy	13 Participants n=178 Participants
Medical History Coronary Artery Disease	61 Participants n=178 Participants
Medical History Prior Myocardial Infarction	22 Participants n=178 Participants
Medical History Atrial Fibrillation	81 Participants n=178 Participants
Medical History Diabetes Mellitus	41 Participants n=178 Participants
Medical History Hypertension	152 Participants n=178 Participants
Medical History Sleep Apnea	47 Participants n=178 Participants
Medical History Chronic Obstructive Pulmonary Disease	23 Participants n=178 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intent-to-treat (ITT) - Primary Endpoint 1 n=178 Participants This group includes 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 who had a qualifying primary safety endpoint event prior to their exit from the study.
Serious Adverse Device Effect (SADE)-Free Rate at 3 Months	98 Percentage of participants without SADE Interval 95.4 to 99.3

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Intent-to-treat (ITT) - Primary Endpoint 1 n=186 Participants This group includes 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 who had a qualifying primary safety endpoint event prior to their exit from the study.
Implant Success Rate of the Solia S Lead in LBB Area	95.7 % of participants with implant success Interval 91.7 to 98.1

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure	Intent-to-treat (ITT) - Primary Endpoint 1 n=139 Participants This group includes 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 who had a qualifying primary safety endpoint event prior to their exit from the study.
Quality of Life (QOL) From Baseline Through 12 Months Post-Implant	11.4 Score on a Scale Interval 7.4 to 15.4

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Intent-to-treat (ITT) - Primary Endpoint 1 n=168 Participants This group includes 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 who had a qualifying primary safety endpoint event prior to their exit from the study.
Serious Adverse Device Effect (SADE)-Free Rate at 6 Months	96.7 Percentage of participants without SADE Interval 93.7 to 98.6

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Intent-to-treat (ITT) - Primary Endpoint 1 n=161 Participants This group includes 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 who had a qualifying primary safety endpoint event prior to their exit from the study.
Serious Adverse Device Effect (SADE)-Free Rate at 12 Months	96.1 Percentage of participants without SADE Interval 92.6 to 98.2

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Intent-to-treat (ITT) - Primary Endpoint 1 n=156 Participants This group includes 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 who had a qualifying primary safety endpoint event prior to their exit from the study.
Pacing Threshold Measurements for Solia S Lead at 3 Months	0.94 Volts @ 0.4ms Standard Deviation 0.26

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Intent-to-treat (ITT) - Primary Endpoint 1 n=162 Participants This group includes 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 who had a qualifying primary safety endpoint event prior to their exit from the study.
Sensing Measurements for Solia S Lead at 3 Months	12.37 mV Standard Deviation 4.16

SECONDARY outcome

Timeframe: 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

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

Outcome measures

Outcome measures
Measure	Intent-to-treat (ITT) - Primary Endpoint 1 n=166 Participants This group includes 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 who had a qualifying primary safety endpoint event prior to their exit from the study.
Pacing Impedance for Solia S Lead at 3 Months	540.4 Impedance (Ω) Standard Deviation 96.4

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Intent-to-treat (ITT) - Primary Endpoint 1 n=146 Participants This group includes 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 who had a qualifying primary safety endpoint event prior to their exit from the study.
Pacing Threshold Measurements for Solia S Lead at 6 Months	0.97 Volts @ 0.4ms Standard Deviation 0.27

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Intent-to-treat (ITT) - Primary Endpoint 1 n=158 Participants This group includes 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 who had a qualifying primary safety endpoint event prior to their exit from the study.
Sensing Measurements for Solia S Lead at 6 Months	12.83 mV Standard Deviation 4.78

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Intent-to-treat (ITT) - Primary Endpoint 1 n=160 Participants This group includes 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 who had a qualifying primary safety endpoint event prior to their exit from the study.
Pacing Impedance for Solia S Lead at 6 Months	526.7 Impedance (Ω) Standard Deviation 96.7

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Intent-to-treat (ITT) - Primary Endpoint 1 n=144 Participants This group includes 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 who had a qualifying primary safety endpoint event prior to their exit from the study.
Pacing Threshold Measurements for Solia S Lead at 12 Months	0.98 Volts @ 0.4ms Standard Deviation 0.29

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Intent-to-treat (ITT) - Primary Endpoint 1 n=152 Participants This group includes 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 who had a qualifying primary safety endpoint event prior to their exit from the study.
Sensing Measurements for Solia S Lead at 12 Months	12.76 mV Standard Deviation 4.83

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Intent-to-treat (ITT) - Primary Endpoint 1 n=155 Participants This group includes 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 who had a qualifying primary safety endpoint event prior to their exit from the study.
Pacing Impedance for Solia S Lead at 12 Months	521.8 Impedance (Ω) Standard Deviation 96.6

Adverse Events

Subjects With a Successful Solia S Implant or Unsuccessful Implant Attempt in the LBBA

Serious events: 52 serious events

Other events: 0 other events

Deaths: 9 deaths

Serious adverse events

Serious adverse events
Measure	Subjects With a Successful Solia S Implant or Unsuccessful Implant Attempt in the LBBA n=186 participants at risk This group includes 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.
Product Issues Solia S LBBA Lead Related - Lead Dislodgement	1.6% 3/186 • Number of events 3 • Overall study duration of 12 months: from implant (or implant attempt) through each subject's exit date Adverse events with onset after consent through the study exit date are collected via site review of subject's medical records and subject interview for 1) enrolled subjects and 2) subjects with an unsuccessful implant attempt or implant not meeting success criteria. If a subject is exited as a screen failure after having started the implant procedure, adverse events potentially related to the device or procedure will be collected.
Surgical and medical procedures Procedure Related - Other Implant Procedure Related Adverse Event	0.54% 1/186 • Number of events 1 • Overall study duration of 12 months: from implant (or implant attempt) through each subject's exit date Adverse events with onset after consent through the study exit date are collected via site review of subject's medical records and subject interview for 1) enrolled subjects and 2) subjects with an unsuccessful implant attempt or implant not meeting success criteria. If a subject is exited as a screen failure after having started the implant procedure, adverse events potentially related to the device or procedure will be collected.
Vascular disorders Procedure Related - Deep Vein Thrombosis	0.54% 1/186 • Number of events 1 • Overall study duration of 12 months: from implant (or implant attempt) through each subject's exit date Adverse events with onset after consent through the study exit date are collected via site review of subject's medical records and subject interview for 1) enrolled subjects and 2) subjects with an unsuccessful implant attempt or implant not meeting success criteria. If a subject is exited as a screen failure after having started the implant procedure, adverse events potentially related to the device or procedure will be collected.
Infections and infestations Procedure Related - Infection	0.54% 1/186 • Number of events 1 • Overall study duration of 12 months: from implant (or implant attempt) through each subject's exit date Adverse events with onset after consent through the study exit date are collected via site review of subject's medical records and subject interview for 1) enrolled subjects and 2) subjects with an unsuccessful implant attempt or implant not meeting success criteria. If a subject is exited as a screen failure after having started the implant procedure, adverse events potentially related to the device or procedure will be collected.
Surgical and medical procedures Procedure Related - Hospital Admission for any Reason Attributable to Implant Procedure	0.54% 1/186 • Number of events 1 • Overall study duration of 12 months: from implant (or implant attempt) through each subject's exit date Adverse events with onset after consent through the study exit date are collected via site review of subject's medical records and subject interview for 1) enrolled subjects and 2) subjects with an unsuccessful implant attempt or implant not meeting success criteria. If a subject is exited as a screen failure after having started the implant procedure, adverse events potentially related to the device or procedure will be collected.
Injury, poisoning and procedural complications Procedure Related - Pneumo or Hemothorax Associated with Implant Procedure	0.54% 1/186 • Number of events 1 • Overall study duration of 12 months: from implant (or implant attempt) through each subject's exit date Adverse events with onset after consent through the study exit date are collected via site review of subject's medical records and subject interview for 1) enrolled subjects and 2) subjects with an unsuccessful implant attempt or implant not meeting success criteria. If a subject is exited as a screen failure after having started the implant procedure, adverse events potentially related to the device or procedure will be collected.
Product Issues Other Implanted System Related - RA Lead Dislodgement	2.2% 4/186 • Number of events 4 • Overall study duration of 12 months: from implant (or implant attempt) through each subject's exit date Adverse events with onset after consent through the study exit date are collected via site review of subject's medical records and subject interview for 1) enrolled subjects and 2) subjects with an unsuccessful implant attempt or implant not meeting success criteria. If a subject is exited as a screen failure after having started the implant procedure, adverse events potentially related to the device or procedure will be collected.
Product Issues Other Implanted System Related - Other Unexpected Complication Related to RA Lead	0.54% 1/186 • Number of events 1 • Overall study duration of 12 months: from implant (or implant attempt) through each subject's exit date Adverse events with onset after consent through the study exit date are collected via site review of subject's medical records and subject interview for 1) enrolled subjects and 2) subjects with an unsuccessful implant attempt or implant not meeting success criteria. If a subject is exited as a screen failure after having started the implant procedure, adverse events potentially related to the device or procedure will be collected.
Product Issues Other Implanted System Related - Other Pulse Generator Related Adverse Event	0.54% 1/186 • Number of events 1 • Overall study duration of 12 months: from implant (or implant attempt) through each subject's exit date Adverse events with onset after consent through the study exit date are collected via site review of subject's medical records and subject interview for 1) enrolled subjects and 2) subjects with an unsuccessful implant attempt or implant not meeting success criteria. If a subject is exited as a screen failure after having started the implant procedure, adverse events potentially related to the device or procedure will be collected.
Product Issues Other Implanted System Related - Abnormal RA Lead Performance	0.54% 1/186 • Number of events 1 • Overall study duration of 12 months: from implant (or implant attempt) through each subject's exit date Adverse events with onset after consent through the study exit date are collected via site review of subject's medical records and subject interview for 1) enrolled subjects and 2) subjects with an unsuccessful implant attempt or implant not meeting success criteria. If a subject is exited as a screen failure after having started the implant procedure, adverse events potentially related to the device or procedure will be collected.
Cardiac disorders Not Implanted System or Procedure Related - Cardiac Disorders	9.1% 17/186 • Number of events 25 • Overall study duration of 12 months: from implant (or implant attempt) through each subject's exit date Adverse events with onset after consent through the study exit date are collected via site review of subject's medical records and subject interview for 1) enrolled subjects and 2) subjects with an unsuccessful implant attempt or implant not meeting success criteria. If a subject is exited as a screen failure after having started the implant procedure, adverse events potentially related to the device or procedure will be collected.
Respiratory, thoracic and mediastinal disorders Not Implanted System or Procedure Related - Respiratory, Thoracic, and Mediastinal Disorders	5.9% 11/186 • Number of events 17 • Overall study duration of 12 months: from implant (or implant attempt) through each subject's exit date Adverse events with onset after consent through the study exit date are collected via site review of subject's medical records and subject interview for 1) enrolled subjects and 2) subjects with an unsuccessful implant attempt or implant not meeting success criteria. If a subject is exited as a screen failure after having started the implant procedure, adverse events potentially related to the device or procedure will be collected.
Surgical and medical procedures Not Implanted System or Procedure Related - Surgical and Medical Procedures	5.4% 10/186 • Number of events 10 • Overall study duration of 12 months: from implant (or implant attempt) through each subject's exit date Adverse events with onset after consent through the study exit date are collected via site review of subject's medical records and subject interview for 1) enrolled subjects and 2) subjects with an unsuccessful implant attempt or implant not meeting success criteria. If a subject is exited as a screen failure after having started the implant procedure, adverse events potentially related to the device or procedure will be collected.
Infections and infestations Not Implanted System or Procedure Related - Infections and Infestations	4.3% 8/186 • Number of events 9 • Overall study duration of 12 months: from implant (or implant attempt) through each subject's exit date Adverse events with onset after consent through the study exit date are collected via site review of subject's medical records and subject interview for 1) enrolled subjects and 2) subjects with an unsuccessful implant attempt or implant not meeting success criteria. If a subject is exited as a screen failure after having started the implant procedure, adverse events potentially related to the device or procedure will be collected.
General disorders Not Implanted System or Procedure Related - General Disorders	4.3% 8/186 • Number of events 8 • Overall study duration of 12 months: from implant (or implant attempt) through each subject's exit date Adverse events with onset after consent through the study exit date are collected via site review of subject's medical records and subject interview for 1) enrolled subjects and 2) subjects with an unsuccessful implant attempt or implant not meeting success criteria. If a subject is exited as a screen failure after having started the implant procedure, adverse events potentially related to the device or procedure will be collected.
Renal and urinary disorders Not Implanted System or Procedure Related - Renal and Urinary Disorders	2.7% 5/186 • Number of events 5 • Overall study duration of 12 months: from implant (or implant attempt) through each subject's exit date Adverse events with onset after consent through the study exit date are collected via site review of subject's medical records and subject interview for 1) enrolled subjects and 2) subjects with an unsuccessful implant attempt or implant not meeting success criteria. If a subject is exited as a screen failure after having started the implant procedure, adverse events potentially related to the device or procedure will be collected.
Gastrointestinal disorders Not Implanted System or Procedure Related - Gastrointestinal Disorders	1.6% 3/186 • Number of events 4 • Overall study duration of 12 months: from implant (or implant attempt) through each subject's exit date Adverse events with onset after consent through the study exit date are collected via site review of subject's medical records and subject interview for 1) enrolled subjects and 2) subjects with an unsuccessful implant attempt or implant not meeting success criteria. If a subject is exited as a screen failure after having started the implant procedure, adverse events potentially related to the device or procedure will be collected.
Hepatobiliary disorders Not Implanted System or Procedure Related - Hepatobiliary Disorders	1.1% 2/186 • Number of events 4 • Overall study duration of 12 months: from implant (or implant attempt) through each subject's exit date Adverse events with onset after consent through the study exit date are collected via site review of subject's medical records and subject interview for 1) enrolled subjects and 2) subjects with an unsuccessful implant attempt or implant not meeting success criteria. If a subject is exited as a screen failure after having started the implant procedure, adverse events potentially related to the device or procedure will be collected.
Vascular disorders Not Implanted System or Procedure Related - Vascular Disorders	2.2% 4/186 • Number of events 4 • Overall study duration of 12 months: from implant (or implant attempt) through each subject's exit date Adverse events with onset after consent through the study exit date are collected via site review of subject's medical records and subject interview for 1) enrolled subjects and 2) subjects with an unsuccessful implant attempt or implant not meeting success criteria. If a subject is exited as a screen failure after having started the implant procedure, adverse events potentially related to the device or procedure will be collected.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Not Implanted System or Procedure Related - Neoplasms Benign, Malignant, and Unspecified	1.6% 3/186 • Number of events 3 • Overall study duration of 12 months: from implant (or implant attempt) through each subject's exit date Adverse events with onset after consent through the study exit date are collected via site review of subject's medical records and subject interview for 1) enrolled subjects and 2) subjects with an unsuccessful implant attempt or implant not meeting success criteria. If a subject is exited as a screen failure after having started the implant procedure, adverse events potentially related to the device or procedure will be collected.
Nervous system disorders Not Implanted System or Procedure Related - Nervous System Disorders	1.1% 2/186 • Number of events 3 • Overall study duration of 12 months: from implant (or implant attempt) through each subject's exit date Adverse events with onset after consent through the study exit date are collected via site review of subject's medical records and subject interview for 1) enrolled subjects and 2) subjects with an unsuccessful implant attempt or implant not meeting success criteria. If a subject is exited as a screen failure after having started the implant procedure, adverse events potentially related to the device or procedure will be collected.
Injury, poisoning and procedural complications Not Implanted System or Procedure Related - Injury, Poisoning and Procedural Complications	1.1% 2/186 • Number of events 2 • Overall study duration of 12 months: from implant (or implant attempt) through each subject's exit date Adverse events with onset after consent through the study exit date are collected via site review of subject's medical records and subject interview for 1) enrolled subjects and 2) subjects with an unsuccessful implant attempt or implant not meeting success criteria. If a subject is exited as a screen failure after having started the implant procedure, adverse events potentially related to the device or procedure will be collected.
Blood and lymphatic system disorders Not Implanted System or Procedure Related - Blood and Lymphatic System Disorders	0.54% 1/186 • Number of events 1 • Overall study duration of 12 months: from implant (or implant attempt) through each subject's exit date Adverse events with onset after consent through the study exit date are collected via site review of subject's medical records and subject interview for 1) enrolled subjects and 2) subjects with an unsuccessful implant attempt or implant not meeting success criteria. If a subject is exited as a screen failure after having started the implant procedure, adverse events potentially related to the device or procedure will be collected.

Other adverse events

Adverse event data not reported

Additional Information

Crystal Miller

BIOTRONIK, Inc.

Phone: (503) 475-4984

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee After publication of trial results, PIs have the right to publish and/or present the results of the study generated or collected at the institution. The sponsor requires 30 days to review the publication and has the right to obtain input from other investigators in the study. Additionally, the sponsor has the right to delete any confidential information or other proprietary information and may extend the review period if this type of information is included.
Publication restrictions are in place

Restriction type: OTHER