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

The purpose of the BIO-CONDUCT study is to demonstrate the safety and effectiveness of the BIOTRONIK Solia S pacing lead when implanted in the left bundle branch (LBB) area. 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: Completed
• Conditions: Left Bundle-Branch Block; Bradycardia; Cardiomyopathies; Atrioventricular Block
• Intervention / Treatment: Device: Solia S lead

• Study Type: Interventional
• Enrollment (Actual): 194
• Phase: Not Applicable

Contacts and Locations

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
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Washington Hospital Center
  • Florida
    • Sarasota, Florida, United States, 34239
      • Sarasota Memorial Health Care System
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
    • Chicago, Illinois, United States, 60637
      • University of Chicago
  • Mississippi
    • Tupelo, Mississippi, United States, 38801
      • Cardiology Associates
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health
    • New York, New York, United States, 10021
      • Weill Cornell Medicine
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Cardiology Consultants of Philadelphia
    • Wilkes-Barre, Pennsylvania, United States, 18711
      • Geisinger
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina (MUSC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (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 Cardiac Resynchronization Therapy with a Pacemaker (CRT-P) systems are allowed.
• Patient has an implant planned to utilize left bundle branch area 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 Implantable Cardioverter-Defibrillator (ICD) device
• Patient has had a previous unsuccessful attempt to place a lead in the LBB area
• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Solia S LBB lead	Device: Solia S lead; The Solia S pacing lead will be implanted in the LBB area for patients who meet all inclusion/exclusion criteria and give written informed consent.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serious Adverse Device Effect (SADE)-Free Rate at 3 Months	The overall rate of serious Solia S Left Bundle Branch (LBB) lead related adverse device effects and serious implant procedure events related to the Solia S LBB lead that occur through 3 months post-implant. The definition of adverse device effect is an untoward medical occurrence (e.g. disease, injury) related to the use of a study device. Pacemaker lead-related examples include events such as lead dislodgements or lead malfunction. The Solia S LBB lead complication-free rate is calculated as the number of subjects without one or more adverse device effect complications divided by the total number of study subjects successfully enrolled and subjects undergoing an unsuccessful implant attempt who have a qualifying primary safety endpoint event. Classification of adverse device related events from the pool of potential events is determined by a clinical events committee (CEC). The complication-free rate is expressed in percent.	3 months post implant
Implant Success Rate of the Solia S Lead in LBB Area	The percentage of subjects with Solia S placed successfully in the LBBA divided by the total number of consented study subjects in whom an implant of Solia S in the LBBA was attempted.	at implant procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life (QOL) From Baseline Through 12 Months Post-Implant	The change in the physical function Short Form-36 (SF-36, 36-Item Short Form Health Survey) QOL subscale was calculated as the mean change from baseline to 12-month follow-up for all subjects that completed both the baseline QOL and 12-month QOL questionnaire. The physical function subscale of Short Form-36 is comprised of ten questions out of the total of 36 questions. The responses to the ten questions relating to physical function were averaged at baseline and at 12 months. The difference in the averages (12 months minus baseline) is reported as the outcome for secondary endpoint 1. Note that each question and each component is scored such that a higher score defines a more favorable health state. Each 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	The overall rate of serious Solia S LBBA lead related adverse device effects and serious implant procedure events related to the Solia S LBBA lead that occur through 6 months post-implant. The Solia S LBBA lead complication-free rate per subject, which was calculated as the number of subjects without one or more complications divided by the total number of study subjects successfully enrolled and subjects undergoing an unsuccessful implant attempt who have a qualifying safety endpoint event. The complication-free rate is expressed in percentage of participants without SADE.	6 months post implant
Serious Adverse Device Effect (SADE)-Free Rate at 12 Months	The overall rate of serious Solia S LBBA lead related adverse device effects and serious implant procedure events related to the Solia S LBBA lead that occur through 12 months post-implant. The Solia S LBBA lead complication-free rate per subject, which was calculated as the number of subjects without one or more complications divided by the total number of study subjects successfully enrolled and subjects undergoing an unsuccessful implant attempt who have a qualifying safety endpoint event. The complication-free rate is expressed in percent.	12 months post implant
Pacing Threshold Measurements for Solia S Lead at 3 Months	Pacing threshold measurements for Solia S leads implanted in the LBBA at the 3 month follow-up visit.	3 months post implant
Sensing Measurements for Solia S Lead at 3 Months	R-wave sensing amplitude measurements for Solia S leads implanted in the LBBA at the 3 month follow-up visit.	3 months post implant
Pacing Impedance for Solia S Lead at 3 Months	Pacing impedance measurements for Solia S leads implanted in the LBBA at the 3 month follow-up visit.	3 months post implant
Pacing Threshold Measurements for Solia S Lead at 6 Months	Pacing threshold measurements for Solia S leads implanted in the LBBA at the 6 month follow-up visit.	6 months post implant
Sensing Measurements for Solia S Lead at 6 Months	R-wave sensing amplitude measurements for Solia S leads implanted in the LBBA at the 6 month follow-up visit.	6 months post implant
Pacing Impedance for Solia S Lead at 6 Months	Pacing impedance measurements for Solia S leads implanted in the LBBA at the 6 month follow-up visit.	6 months post implant
Pacing Threshold Measurements for Solia S Lead at 12 Months	Pacing threshold measurements for Solia S leads implanted in the LBBA at the 12 month follow-up visit.	12 months post implant
Sensing Measurements for Solia S Lead at 12 Months	R-wave sensing amplitude measurements for Solia S leads implanted in the LBBA at the 12 month follow-up visit.	12 months post implant
Pacing Impedance for Solia S Lead at 12 Months	Pacing impedance measurements for Solia S leads implanted in the LBBA at the 12 month follow-up visit.	12 months post implant

Collaborators and Investigators

• Sponsor: Biotronik, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2022
• Primary Completion (Actual): January 9, 2024
• Study Completion (Actual): October 8, 2024

Study Registration Dates

• First Submitted: February 7, 2022
• First Submitted That Met QC Criteria: February 16, 2022
• First Posted (Actual): February 22, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 27, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiac Conduction System Disease; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Heart Block; Atrioventricular Block; Cardiomyopathies; Bundle-Branch Block; Bradycardia
• Other Study ID Numbers: G210349

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.
• 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