Sinus Node DysfunctionBIO-CONDUCTNCT06540079
BIOTRONIK Conduction System Pacing With the Solia Lead - Solia CSP S
A study testing Solia CSP S lead in people with Sinus Node Dysfunction and Bradycardia, run by Biotronik, Inc. at 10 sites in United States.
Trial summary
The purpose of the BIO-CONDUCT study is to demonstrate the safety and effectiveness of the BIOTRONIK Solia CSP S pacing lead when implanted in the left bundle branch area (LBBA). 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
- Sinus Node Dysfunction, Bradycardia, Atrioventricular Block
- What is being tested?
- Solia CSP S lead
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 10 sitesUnited States
- Study dates
- 18 Dec 2024to 17 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 CRT-P systems are allowed.
- Patient has an implant planned to utilize left bundle branch area (LBBA) 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 ICD device
- Patient has had a previous unsuccessful attempt to place a lead in the LBBA
- 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
10 sites in 1 country.
10 sites in 1 country
United States10 sites
University of Chicago
Chicago, Illinois, 60637
NYU Heart Rhythm Center
New York, New York, 10016
Weill Cornell Medicine
New York, New York, 10021
Cardiology Consultants of Philadelphia
Paoli, Pennsylvania, 19301
Banner - University Medical Center Phoenix
Phoenix, Arizona, 85006
Sarasota Memorial Hospital
Sarasota, Florida, 34239
Cardiology Associates Research, LLC
Tupelo, Mississippi, 38801
Cardiology Associates Medical Group
Ventura, California, 93003
Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, 18711
Atrium Health Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
Official title: BIOTRONIK Conduction System Pacing With the Solia Lead
The purpose of the BIO-CONDUCT study is to demonstrate the safety and effectiveness of the BIOTRONIK Solia CSP S pacing lead when implanted in the left bundle branch area (LBBA). 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.
- Conditions
- Sinus Node Dysfunction, Bradycardia, Atrioventricular Block
- Being tested
- Solia CSP S lead
- Medical subject headings
- Sick Sinus Syndrome, Bradycardia, Atrioventricular Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solia CSP S leadDevice
The Solia CSP S pacing lead will be implanted in the LBBA for patients who meet all inclusion/exclusion criteria and give written informed consent.
| Study group | Role | What they receive |
|---|---|---|
| Solia CSP S LBB Lead | Experimental | Not described Receives: Device: Solia CSP 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
Serious adverse device effect includes both serious lead related and serious implant related device effects. The overall percentage of subjects without serious lead related adverse device effects related to Solia CSP S lead utilized or attempted to be implanted in the LBBA and serious implant procedure events related to the Solia CSP S LBBA lead will be reported.
Measured: 3 months post-implant
Implant Success Rate
The overall percentage of subjects with successful placement of Solia CSP S lead in LBBA will be reported.
Measured: At implant procedure
Secondary outcomes (12)
Quality of Life (QOL) from Baseline through 12 Months Post-Implant
This secondary outcome will evaluate the improvement in QOL for subjects with the Solia CSP S lead implanted in the LBBA. The parameter of interest is the change in the physical function SF-36 (36-Item Short Form Health Survey) QOL scale from pre-implant baseline to 12 months post-implant, which will be calculated as the mean change from baseline for all subjects that complete both the baseline QOL and 12-month QOL questionnaire. Note that all items are scored so that a high score defines a more favorable health state. Each item 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
Serious adverse device effect includes both serious lead related and serious implant related device effects. The overall percentage of subjects without serious lead related adverse device effects related to Solia CSP S lead utilized or attempted to be implanted in the LBBA and serious implant procedure events related to the Solia CSP S LBBA lead will be reported.
Measured: 6 months post-implant
Serious Adverse Device Effect (SADE)-Free Rate at 12 Months
Serious adverse device effect includes both serious lead related and serious implant related device effects. The overall percentage of subjects without serious lead related adverse device effects related to Solia CSP S lead utilized or attempted to be implanted in the LBBA and serious implant procedure events related to the Solia CSP S LBBA lead will be reported.
Measured: 12 months post-implant
Pacing Threshold Measurements at 3 Months
Pacing threshold measurements for Solia CSP S leads implanted in the LBBA at the 3 month follow-up visit.
Measured: 3 months post-implant
Sensing Measurements at 3 Months
R-wave sensing amplitude measurements for Solia CSP S leads implanted in the LBBA at the 3 month follow-up visit.
Measured: 3 months post-implant
Pacing Impedance at 3 Months
Pacing impedance measurements for Solia CSP S leads implanted in the LBBA at the 3 month follow-up visit.
Measured: 3 months post-implant
Pacing Threshold Measurements at 6 Months
Pacing threshold measurements for Solia CSP S leads implanted in the LBBA at the 6 month follow-up visit.
Measured: 6 months post-implant
Sensing Measurements at 6 Months
R-wave sensing amplitude measurements for Solia CSP S leads implanted in the LBBA at the 6 month follow-up visit.
Measured: 6 months post-implant
Pacing Impedance at 6 Months
Pacing impedance measurements for Solia CSP S leads implanted in the LBBA at the 6 month follow-up visit.
Measured: 6 months post-implant
Pacing Threshold Measurements at 12 Months
Pacing threshold measurements for Solia CSP S leads implanted in the LBBA at the 12 month follow-up visit.
Measured: 12 months post-implant
Sensing Measurements at 12 Months
R-wave sensing amplitude measurements for Solia CSP S leads implanted in the LBBA at the 12 month follow-up visit.
Measured: 12 months post-implant
Pacing Impedance at 12 Months
Pacing impedance measurements for Solia CSP 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.
- First posted6 Aug 2024
- Study start18 Dec 2024
- Primary completion18 Sep 2025
- Study completion17 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sinus Node DysfunctionStudies 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
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06540079
- Sponsor's protocol ID
- G210349-Solia CSP S
- Acronym
- BIO-CONDUCT
- Status last verified
- Jun 2026
- First submitted
- 2 Aug 2024
- Last updated
- 14 Jul 2026
- Results posted
- No
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. 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
- NCT06540079
- Acronym / sponsor ID
- BIO-CONDUCT / G210349-Solia CSP S
- Conditions
- Sinus Node Dysfunction, Bradycardia, Atrioventricular Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Biotronik, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Dec 2024 (actual)
- Primary completion
- 18 Sep 2025 (actual)
- Study completion
- 17 Jun 2026 (actual)
- First posted
- 6 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the BIO-CONDUCT study is to demonstrate the safety and effectiveness of the BIOTRONIK Solia CSP S pacing lead when implanted in the left bundle branch area (LBBA). 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Solia CSP S LBB Lead | Experimental | Device: Solia CSP 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 CRT-P systems are allowed.
- Patient has an implant planned to utilize left bundle branch area (LBBA) 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 ICD device
- Patient has had a previous unsuccessful attempt to place a lead in the LBBA
- 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 CSP S leadThe Solia CSP S pacing lead will be implanted in the LBBA for patients who meet all inclusion/exclusion criteria and give written informed consent. | Device | Solia CSP S LBB Lead |
Primary outcome
Serious Adverse Device Effect (SADE)-Free Rate at 3 Months
Time frame: 3 months post-implant
Serious adverse device effect includes both serious lead related and serious implant related device effects. The overall percentage of subjects without serious lead related adverse device effects related to Solia CSP S lead utilized or attempted to be implanted in the LBBA and serious implant procedure events related to the Solia CSP S LBBA lead will be reported.
Implant Success Rate
Time frame: At implant procedure
The overall percentage of subjects with successful placement of Solia CSP S lead in LBBA will be reported.
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 at 3 Months
Time frame: 3 months post-implant
Sensing Measurements at 3 Months
Time frame: 3 months post-implant
Pacing Impedance at 3 Months
Time frame: 3 months post-implant
Pacing Threshold Measurements at 6 Months
Time frame: 6 months post-implant
Sensing Measurements at 6 Months
Time frame: 6 months post-implant
Pacing Impedance at 6 Months
Time frame: 6 months post-implant
Pacing Threshold Measurements at 12 Months
Time frame: 12 months post-implant
Sensing Measurements at 12 Months
Time frame: 12 months post-implant
Pacing Impedance at 12 Months
Time frame: 12 months post-implant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: Yes. De-identified participant level data collected within the study will be shared for approved requests.
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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.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Solia CSP S lead in people with Sinus Node Dysfunction and Bradycardia, run by Biotronik, Inc. at 10 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 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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 14 Jul 2026.