BradycardiaBIO-CONDUCTNCT05251363

BIOTRONIK Conduction System Pacing With the Solia Lead

A study testing Solia S lead in people with Bradycardia and Atrioventricular Block, run by Biotronik, Inc. at 14 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Bradycardia, Atrioventricular Block, Left Bundle-Branch Block
What is being tested?: Solia S lead
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 194 participants
Where: 14 sitesUnited States
Study dates: 12 Dec 2022to 8 Oct 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 9Show fewer

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

Trial locations and contacts

14 sites in 1 country.

City, postcode or hospital

14 sites in 1 country

United States14 sites

Medical University of South Carolina (MUSC)
Charleston, South Carolina, 29425
Rush University Medical Center
Chicago, Illinois, 60612
University of Chicago
Chicago, Illinois, 60637
NYU Langone Health
New York, New York, 10016
Weill Cornell Medicine
New York, New York, 10021
Cardiology Consultants of Philadelphia
Philadelphia, Pennsylvania, 19107
Banner - University Medical Center Phoenix
Phoenix, Arizona, 85006
Sarasota Memorial Health Care System
Sarasota, Florida, 34239
Tampa General Hospital
Tampa, Florida, 33606
Cardiology Associates
Tupelo, Mississippi, 38801
Cardiology Associates Medical Group
Ventura, California, 93003
Washington Hospital Center
Washington D.C., District of Columbia, 20010
Geisinger
Wilkes-Barre, Pennsylvania, 18711
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Conditions: Bradycardia, Atrioventricular Block, Left Bundle-Branch Block, Cardiomyopathies
Being tested: Solia S lead
Medical subject headings: Bradycardia, Atrioventricular Block, Bundle-Branch Block, Cardiomyopathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Solia S leadDevice
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.

Study groups in NCT05251363
Study group	Role	What they receive
Solia S LBB lead	Other	Not described Receives: Device: Solia S lead

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: at implant procedure

Secondary outcomes (12)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months post implant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Dec 20228 Oct 2024

First posted22 Feb 2022
Study start12 Dec 2022
Primary completion9 Jan 2024
Study completion8 Oct 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for BradycardiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 194 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05251363
Sponsor's protocol ID: G210349
Acronym: BIO-CONDUCT
Status last verified: Feb 2025
First submitted: 7 Feb 2022
Last updated: 18 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Yes: De-identified participant level data collected within the study will be shared for approved requests.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
Safety, Performance, and Clinical Benefit of Pacing the Left Bundle Branch Area - Post-Market Clinical Follow-up
Bradycardia, Atrioventricular Block
RecruitingObservational study
BIO|STREAM.CSP Study
Cardiac Pacing, Cardiac Pacemaker
Active, not recruiting
BIO|MASTER.CSP Study
Cardiac Pacing, Artificial, Cardiac Pacemaker, Artificial
Recruiting
SPIKE FLOW Endocardial Lead Safety and Performance Study
Acute Myocardial Infarction (AMI), Asystole
Active, not recruitingObservational study
AVEIR DR Coverage With Evidence Development (CED) Study
Cardiac Pacemaker, Arrythmia

All Bradycardia trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: BIOTRONIK Conduction System Pacing With the Solia Lead
ClinicalTrials.gov ID: NCT05251363
Acronym / sponsor ID: BIO-CONDUCT / G210349
Conditions: Bradycardia, Atrioventricular Block, Left Bundle-Branch Block, Cardiomyopathies
Study type: Interventional
Recruitment status: Completed
Enrolment: 194 participants (actual)
Lead sponsor: Biotronik, Inc.Industry (pharma, biotech, devices)
Study start: 12 Dec 2022 (actual)
Primary completion: 9 Jan 2024 (actual)
Study completion: 8 Oct 2024 (actual)
First posted: 22 Feb 2022 (actual)
Results: Posted 18 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Solia S LBB lead	Other	Device: Solia S lead

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Solia S leadThe Solia S pacing lead will be implanted in the LBB area for patients who meet all inclusion/exclusion criteria and give written informed consent.	Device	Solia S LBB lead

Primary outcome

Serious Adverse Device Effect (SADE)-Free Rate at 3 Months
Time frame: 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
Time frame: 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.

12 secondary outcomes

Quality of Life (QOL) From Baseline Through 12 Months Post-Implant
Time frame: 12 months post implant
Serious Adverse Device Effect (SADE)-Free Rate at 6 Months
Time frame: 6 months post implant
Serious Adverse Device Effect (SADE)-Free Rate at 12 Months
Time frame: 12 months post implant
Pacing Threshold Measurements for Solia S Lead at 3 Months
Time frame: 3 months post implant
Sensing Measurements for Solia S Lead at 3 Months
Time frame: 3 months post implant
Pacing Impedance for Solia S Lead at 3 Months
Time frame: 3 months post implant
Pacing Threshold Measurements for Solia S Lead at 6 Months
Time frame: 6 months post implant
Sensing Measurements for Solia S Lead at 6 Months
Time frame: 6 months post implant
Pacing Impedance for Solia S Lead at 6 Months
Time frame: 6 months post implant
Pacing Threshold Measurements for Solia S Lead at 12 Months
Time frame: 12 months post implant
Sensing Measurements for Solia S Lead at 12 Months
Time frame: 12 months post implant
Pacing Impedance for Solia S Lead at 12 Months
Time frame: 12 months post implant

Results and safety

Results posted to the registry on 18 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Solia S LBB Lead	186	178

Primary outcome: Serious Adverse Device Effect (SADE)-Free Rate at 3 Months

Time frame: 3 months post implant. Number (95% Confidence Interval). Unit: Percentage of participants without SADE

Measure	Intent-to-treat (ITT) - Primary Endpoint 1 n = 178
Value	98 (95.4 to 99.3)

Intent-to-treat (ITT) - Primary Endpoint 1: p <0.0001, Exact binomial test

Population analysed: 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.

Primary outcome: Implant Success Rate of the Solia S Lead in LBB Area

Time frame: at implant procedure. Number (95% Confidence Interval). Unit: % of participants with implant success

Measure	Intent-to-Treat (ITT) - Primary Endpoint 2 (Efficacy) n = 186
Value	95.7 (91.7 to 98.1)

Intent-to-Treat (ITT) - Primary Endpoint 2 (Efficacy): p < 0.0001, Exact binomial test

Population analysed: 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.

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: Overall study duration of 12 months: from implant (or implant attempt) through each subject's exit date. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Subjects With a Successful Solia S Implant or Unsuccessful Implant Attempt in the LBBA	52 of 186 (28%)	0 of 186 (0%)	9 of 186

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. De-identified participant level data collected within the study will be shared for approved requests.

Related trials for Bradycardia

Active, not recruitingObservational study
Safety, Performance, and Clinical Benefit of Pacing the Left Bundle Branch Area - Post-Market Clinical Follow-up
Bradycardia, Atrioventricular Block
RecruitingObservational study
BIO|STREAM.CSP Study
Cardiac Pacing, Cardiac Pacemaker
Active, not recruiting
BIO|MASTER.CSP Study
Cardiac Pacing, Artificial, Cardiac Pacemaker, Artificial
Recruiting
SPIKE FLOW Endocardial Lead Safety and Performance Study
Acute Myocardial Infarction (AMI), Asystole
Active, not recruitingObservational study
AVEIR DR Coverage With Evidence Development (CED) Study
Cardiac Pacemaker, Arrythmia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

14 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Solia S lead in people with Bradycardia and Atrioventricular Block, run by Biotronik, Inc. at 14 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serious Adverse Device Effect (SADE)-Free Rate at 3 Months (time frame: 3 months post implant). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05251363.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025.