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

Last updated: April 23, 2025
Sponsor: Biotronik, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Arrhythmia

Low Blood Pressure (Hypotension)

Dysrhythmia

Treatment

Solia CSP S lead

Clinical Study ID

NCT06540079
G210349-Solia CSP S
  • Ages > 18
  • All Genders

Study 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. Efficacy will be assessed by evaluating implant success rate.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient is a candidate for implantation of a BIOTRONIK pacemaker system, perstandard guidelines. Single chamber, dual chamber, and CRT-P systems are allowed.

  • Patient has an implant planned to utilize left bundle branch area (LBBA) pacingwithin 30 days of consent

  • Patient is able to understand the nature of the study and provide written informedconsent

  • Patient is available for follow-up visits on a regular basis for the expectedduration of follow-up

  • Patient accepts Home Monitoring® concept

  • Patient age is greater than or equal to 18 years at time of consent

Exclusion

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 3months 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 separatefrom their cardiac disorder

  • Patient reports pregnancy at the time of enrollment

  • Patient is enrolled in any other investigational cardiac clinical study during thecourse of the study

Study Design

Total Participants: 110
Treatment Group(s): 1
Primary Treatment: Solia CSP S lead
Phase:
Study Start date:
December 18, 2024
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • Banner - University Medical Center Phoenix

    Phoenix, Arizona 85006
    United States

    Active - Recruiting

  • Cardiology Associates Medical Group

    Ventura, California 93003
    United States

    Active - Recruiting

  • Sarasota Memorial Hospital

    Sarasota, Florida 34239
    United States

    Active - Recruiting

  • University of Chicago

    Chicago, Illinois 60637
    United States

    Active - Recruiting

  • Cardiology Associates Research, LLC

    Tupelo, Mississippi 38801
    United States

    Active - Recruiting

  • NYU Heart Rhythm Center

    New York, New York 10016
    United States

    Active - Recruiting

  • Weill Cornell Medicine

    New York, New York 10021
    United States

    Active - Recruiting

  • Atrium Health Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina 27157
    United States

    Active - Recruiting

  • Cardiology Consultants of Philadelphia

    Paoli, Pennsylvania 19301
    United States

    Active - Recruiting

  • Geisinger Wyoming Valley Medical Center

    Wilkes-Barre, Pennsylvania 18711
    United States

    Active - Recruiting

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