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Completed

NCT Number: NCT06540079

BIOTRONIK Conduction System Pacing With the Solia Lead - Solia CSP S

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.

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Key information

Conditions

Sinus Node Dysfunction Arrhythmia, Sinus Arrhythmias, Cardiac Atrioventricular Block Bradycardia Cardiac Conduction System Disease Cardiovascular Diseases Heart Block Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Sick Sinus Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Banner - University Medical Center Phoenix, Phoenix, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Solia CSP S lead

Device

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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. 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.

Sponsors and collaborators

Lead sponsor

Biotronik, Inc.

Industry

Registry information

Official study title

BIOTRONIK Conduction System Pacing With the Solia Lead

Acronym: BIO-CONDUCT

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Aug 6, 2024
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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