BIOTRONIK Conduction System Pacing With the Solia Lead - Solia CSP S (BIO-CONDUCT)

July 13, 2026 updated by: Biotronik, Inc.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
192

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Banner - University Medical Center Phoenix
    • California
      • Ventura, California, United States, 93003
        • Cardiology Associates Medical Group
    • Florida
      • Sarasota, Florida, United States, 34239
        • Sarasota Memorial Hospital
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University Of Chicago
    • Mississippi
      • Tupelo, Mississippi, United States, 38801
        • Cardiology Associates Research, Llc
    • New York
      • New York, New York, United States, 10021
        • Weill Cornell Medicine
      • New York, New York, United States, 10016
        • NYU Heart Rhythm Center
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Atrium Health Wake Forest Baptist Medical Center
    • Pennsylvania
      • Paoli, Pennsylvania, United States, 19301
        • Cardiology Consultants of Philadelphia
      • Wilkes-Barre, Pennsylvania, United States, 18711
        • Geisinger Wyoming Valley Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Solia CSP S LBB Lead
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
3 months post-implant
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.
At implant procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Quality of Life (QOL) from Baseline through 12 Months Post-Implant
Time Frame: 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.
12 months post-implant
Serious Adverse Device Effect (SADE)-Free Rate at 6 Months
Time Frame: 6 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.
6 months post-implant
Serious Adverse Device Effect (SADE)-Free Rate at 12 Months
Time Frame: 12 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.
12 months post-implant
Pacing Threshold Measurements at 3 Months
Time Frame: 3 months post-implant
Pacing threshold measurements for Solia CSP S leads implanted in the LBBA at the 3 month follow-up visit.
3 months post-implant
Sensing Measurements at 3 Months
Time Frame: 3 months post-implant
R-wave sensing amplitude measurements for Solia CSP S leads implanted in the LBBA at the 3 month follow-up visit.
3 months post-implant
Pacing Impedance at 3 Months
Time Frame: 3 months post-implant
Pacing impedance measurements for Solia CSP S leads implanted in the LBBA at the 3 month follow-up visit.
3 months post-implant
Pacing Threshold Measurements at 6 Months
Time Frame: 6 months post-implant
Pacing threshold measurements for Solia CSP S leads implanted in the LBBA at the 6 month follow-up visit.
6 months post-implant
Sensing Measurements at 6 Months
Time Frame: 6 months post-implant
R-wave sensing amplitude measurements for Solia CSP S leads implanted in the LBBA at the 6 month follow-up visit.
6 months post-implant
Pacing Impedance at 6 Months
Time Frame: 6 months post-implant
Pacing impedance measurements for Solia CSP S leads implanted in the LBBA at the 6 month follow-up visit.
6 months post-implant
Pacing Threshold Measurements at 12 Months
Time Frame: 12 months post-implant
Pacing threshold measurements for Solia CSP S leads implanted in the LBBA at the 12 month follow-up visit.
12 months post-implant
Sensing Measurements at 12 Months
Time Frame: 12 months post-implant
R-wave sensing amplitude measurements for Solia CSP S leads implanted in the LBBA at the 12 month follow-up visit.
12 months post-implant
Pacing Impedance at 12 Months
Time Frame: 12 months post-implant
Pacing impedance measurements for Solia CSP S leads implanted in the LBBA at the 12 month follow-up visit.
12 months post-implant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biotronik, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 18, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 18, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 17, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 2, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 2, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 6, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • G210349-Solia CSP S

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified participant level data collected within the study will be shared for approved requests.

IPD Sharing Time Frame

The data will be available beginning no later than 12 months and ending 3 years after study completion.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings