An interventional study of Solia CSP S lead in Sinus Node Dysfunction, Bradycardia and Atrioventricular Block, sponsored by Biotronik, Inc.. Completed at 10 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-14.
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 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.
93 studies on the registry are indexed under Sick Sinus Syndrome; 18 are open to participants now.
This study's enrollment of 192 is above the median of 137 across 62 interventional studies indexed under Sick Sinus Syndrome.
Browse Sick Sinus Syndrome studies →Biotronik, Inc. is the lead sponsor of 32 studies on the registry; 1 is open to participants now.
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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 CSP S lead
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.
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.
Time frame: 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.
Time frame: At implant procedure
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months post-implant
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 completion.
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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This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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