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

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: Active, not recruiting
• Conditions: Bradycardia; Atrioventricular Block; Sinus Node Dysfunction
• Intervention / Treatment: Device: Solia CSP S lead

• Study Type: Interventional
• Enrollment (Actual): 192
• 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
  • 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

Eligibility Criteria

• 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

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
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

Outcome Measure	Measure Description	Time Frame
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.	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.	At implant procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	12 months post-implant

Collaborators and Investigators

• Sponsor: Biotronik, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2024
• Primary Completion (Actual): September 18, 2025
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: August 2, 2024
• First Submitted That Met QC Criteria: August 2, 2024
• First Posted (Actual): August 6, 2024

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: February 1, 2026

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; Arrhythmia, Sinus; Pathological Conditions, Signs and Symptoms; Atrioventricular Block; Sick Sinus Syndrome; Bradycardia
• Other Study ID 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