An interventional study of Solia S lead in Bradycardia, Atrioventricular Block and Left Bundle-Branch Block, sponsored by Biotronik, Inc.. Completed at 14 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-18.
Sponsored by Biotronik, Inc. · Not applicable, Interventional, and Treatment
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.
317 studies on the registry are indexed under Bradycardia; 71 are open to participants now.
This study's enrollment of 194 is above the median of 100 across 187 interventional studies indexed under Bradycardia.
Browse Bradycardia studies →Biotronik, Inc. is the lead sponsor of 32 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Solia 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.
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
| Milestone | Solia S LBB Lead |
|---|---|
| Started | 186 |
| Completed | 178 |
| Not completed | 8 |
| Withdrew: Subject did not meet lbba implant criteria | 8 |
| Milestone | Solia S LBB Lead |
|---|---|
| Started | 178 |
| Protocol follow-up: 3-month | 167 |
| Protocol follow-up: 6-month | 163 |
| Protocol follow-up (final): 12-month | 155 |
| Completed | 155 |
| Not completed | 23 |
| Withdrew: Death | 9 |
| Withdrew: Solia s lead in lbba position extracted | 4 |
| Withdrew: Withdrawal by subject | 4 |
| Withdrew: Lost to follow-up | 2 |
| Withdrew: Physician decision | 1 |
| Withdrew: Subject moved from investigational center | 3 |
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.
| Percentage of participants without SADE | Intent-to-treat (ITT) - Primary Endpoint 1 |
|---|---|
| Serious Adverse Device Effect (SADE)-Free Rate at 3 Months | 98 (95.4 to 99.3) |
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.
| % of participants with implant success | Intent-to-Treat (ITT) - Primary Endpoint 2 (Efficacy) |
|---|---|
| Implant Success Rate of the Solia S Lead in LBB Area | 95.7 (91.7 to 98.1) |
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.
| Score on a Scale | Intent-to-Treat (ITT) - Secondary Endpoint 1 (QOL) |
|---|---|
| Quality of Life (QOL) From Baseline Through 12 Months Post-Implant | 11.4 (7.4 to 15.4) |
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.
| Percentage of participants without SADE | Intent-to-Treat (ITT) - Secondary Endpoint 2 (SADE-Free Rate at 6-Mo) |
|---|---|
| Serious Adverse Device Effect (SADE)-Free Rate at 6 Months | 96.7 (93.7 to 98.6) |
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.
| Percentage of participants without SADE | Intent-to-Treat (ITT) - Secondary Endpoint 2 (SADE-Free Rate at 12-Mo) |
|---|---|
| Serious Adverse Device Effect (SADE)-Free Rate at 12 Months | 96.1 (92.6 to 98.2) |
Pacing threshold measurements for Solia S leads implanted in the LBBA at the 3 month follow-up visit.
| Volts @ 0.4ms | Intent-to-Treat (ITT) - Secondary Endpoint 3 (Pacing Threshold at 3-Mo) |
|---|---|
| Pacing Threshold Measurements for Solia S Lead at 3 Months | 0.94 ± 0.26 |
R-wave sensing amplitude measurements for Solia S leads implanted in the LBBA at the 3 month follow-up visit.
| mV | Intent-to-Treat (ITT) - Secondary Endpoint 4 (R-wave Sensed Amplitude at 3-Mo) |
|---|---|
| Sensing Measurements for Solia S Lead at 3 Months | 12.37 ± 4.16 |
Pacing impedance measurements for Solia S leads implanted in the LBBA at the 3 month follow-up visit.
| Impedance (Ω) | Intent-to-Treat (ITT) - Secondary Endpoint 5 (Pacing Impedance at 3-Mo) |
|---|---|
| Pacing Impedance for Solia S Lead at 3 Months | 540.4 ± 96.4 |
Pacing threshold measurements for Solia S leads implanted in the LBBA at the 6 month follow-up visit.
| Volts @ 0.4ms | Intent-to-Treat (ITT) - Secondary Endpoint 3 (Pacing Threshold at 6-Mo) |
|---|---|
| Pacing Threshold Measurements for Solia S Lead at 6 Months | 0.97 ± 0.27 |
R-wave sensing amplitude measurements for Solia S leads implanted in the LBBA at the 6 month follow-up visit.
| mV | Intent-to-Treat (ITT) - Secondary Endpoint 4 (R-wave Sensed Amplitude at 6-Mo) |
|---|---|
| Sensing Measurements for Solia S Lead at 6 Months | 12.83 ± 4.78 |
Pacing impedance measurements for Solia S leads implanted in the LBBA at the 6 month follow-up visit.
| Impedance (Ω) | Intent-to-Treat (ITT) - Secondary Endpoint 5 (Pacing Impedance at 6-Mo) |
|---|---|
| Pacing Impedance for Solia S Lead at 6 Months | 526.7 ± 96.7 |
Pacing threshold measurements for Solia S leads implanted in the LBBA at the 12 month follow-up visit.
| Volts @ 0.4ms | Intent-to-Treat (ITT) - Secondary Endpoint 3 (Pacing Threshold at 12-Mo) |
|---|---|
| Pacing Threshold Measurements for Solia S Lead at 12 Months | 0.98 ± 0.29 |
R-wave sensing amplitude measurements for Solia S leads implanted in the LBBA at the 12 month follow-up visit.
| mV | Intent-to-Treat (ITT) - Secondary Endpoint 4 (R-wave Sensed Amplitude at 12-Mo) |
|---|---|
| Sensing Measurements for Solia S Lead at 12 Months | 12.76 ± 4.83 |
Pacing impedance measurements for Solia S leads implanted in the LBBA at the 12 month follow-up visit.
| Impedance (Ω) | Intent-to-Treat (ITT) - Secondary Endpoint 5 (Pacing Impedance at 12-Mo) |
|---|---|
| Pacing Impedance for Solia S Lead at 12 Months | 521.8 ± 96.6 |
Collected over Overall study duration of 12 months: from implant (or implant attempt) through each subject's exit date. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Subjects With a Successful Solia S Implant or Unsuccessful Implant Attempt in the LBBA | 9/186 (4.8%) | 52/186 (28%) | 0/186 (0%) |
| Event | Subjects With a Successful Solia S Implant or Unsuccessful Implant Attempt in the LBBA |
|---|---|
| Not Implanted System or Procedure Related - Cardiac DisordersCardiac disorders | 17/186 |
| Not Implanted System or Procedure Related - Respiratory, Thoracic, and Mediastinal DisordersRespiratory, thoracic and mediastinal disorders | 11/186 |
| Not Implanted System or Procedure Related - Surgical and Medical ProceduresSurgical and medical procedures | 10/186 |
| Not Implanted System or Procedure Related - Infections and InfestationsInfections and infestations | 8/186 |
| Not Implanted System or Procedure Related - General DisordersGeneral disorders | 8/186 |
| Not Implanted System or Procedure Related - Renal and Urinary DisordersRenal and urinary disorders | 5/186 |
| Other Implanted System Related - RA Lead DislodgementProduct Issues | 4/186 |
| Not Implanted System or Procedure Related - Vascular DisordersVascular disorders | 4/186 |
| Solia S LBBA Lead Related - Lead DislodgementProduct Issues | 3/186 |
| Not Implanted System or Procedure Related - Gastrointestinal DisordersGastrointestinal disorders | 3/186 |
| Age, Continuous(Years) | Subjects With a Successful Solia S Implant in the LBBA |
|---|---|
| Mean | 76.2 ± 9.12 |
| Sex: Female, Male(Participants) | Subjects With a Successful Solia S Implant in the LBBA |
|---|---|
| Female | 65 |
| Male | 113 |
| Ethnicity (NIH/OMB)(Participants) | Subjects With a Successful Solia S Implant in the LBBA |
|---|---|
| Hispanic or Latino | 8 |
| Not Hispanic or Latino | 156 |
| Unknown or Not Reported | 14 |
| Race (NIH/OMB)(Participants) | Subjects With a Successful Solia S Implant in the LBBA |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 2 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 15 |
| White | 142 |
| More than one race | 1 |
| Unknown or Not Reported | 17 |
| Height(Inches) | Subjects With a Successful Solia S Implant in the LBBA |
|---|---|
| Mean | 67.4 ± 4.23 |
| Weight(Pounds) | Subjects With a Successful Solia S Implant in the LBBA |
|---|---|
| Mean | 186.3 ± 41.66 |
| BMI(kg/m²) | Subjects With a Successful Solia S Implant in the LBBA |
|---|---|
| Mean | 28.8 ± 5.43 |
| Medical History(Participants) | Subjects With a Successful Solia S Implant in the LBBA |
|---|---|
| Heart Failure | 44 |
| Cardiomyopathy | 13 |
| Coronary Artery Disease | 61 |
| Prior Myocardial Infarction | 22 |
| Atrial Fibrillation | 81 |
| Diabetes Mellitus | 41 |
| Hypertension | 152 |
| Sleep Apnea | 47 |
| Chronic Obstructive Pulmonary Disease | 23 |
| Cerebrovascular Disease (e.g., TIA / Stroke) | 33 |
| Chronic Kidney Disease (CKD) | 44 |
| Valvular Heart Disease | 46 |
| Peripheral Artery Disease | 16 |
2 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — De-identified participant level data collected within the study will be shared for approved requests.
Supporting information: Study protocol, Statistical analysis plan
Time frame: The data will be available beginning no later than 12 months and ending 3 years after study.
Access criteria: Proposals should be directed to BIOTRONIK Clinical Studies (BIOTRONIK Inc., Attn: Clinical Studies, 6024 Jean Road, Lake Oswego, OR; 1-800-547-0394). BIOTRONIK, in consultation with the National Principal Investigator, will review and critique requests for scientific merit, fiscal feasibility, and logistical feasibility. If approved, the data requestors will need to sign a data use/access agreement prior to obtaining the data. BIOTRONIK reserves the right to delete any confidential information or other proprietary information (including trade secrets and patent protected materials) from the shared information.
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