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

NCT06540079 | Active Not Recruiting FDA Device

• 1 other identifier: G210349-Solia CSP S
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Sinus Node Dysfunction; Bradycardia; Atrioventricular Block

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (12)

• Quality of Life (QOL) from Baseline through 12 Months Post-Implant

  12 months post-implant

• Serious Adverse Device Effect (SADE)-Free Rate at 6 Months

  6 months post-implant

• Serious Adverse Device Effect (SADE)-Free Rate at 12 Months

  12 months post-implant

• Pacing Threshold Measurements at 3 Months

  3 months post-implant

• Sensing Measurements at 3 Months

  3 months post-implant

Study Arms (1)

Solia CSP S LBB Lead

EXPERIMENTAL

Device: Solia CSP S lead

Interventions

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.

Solia CSP S LBB Lead

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biotronik, Inc.: lead

Study Sites (10)

Banner - University Medical Center Phoenix

Phoenix, Arizona, 85006, United States

Location

Cardiology Associates Medical Group

Ventura, California, 93003, United States

Location

Sarasota Memorial Hospital

Sarasota, Florida, 34239, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Cardiology Associates Research, LLC

Tupelo, Mississippi, 38801, United States

Location

NYU Heart Rhythm Center

New York, New York, 10016, United States

Location

Weill Cornell Medicine

New York, New York, 10021, United States

Location

Atrium Health Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

Cardiology Consultants of Philadelphia

Paoli, Pennsylvania, 19301, United States

Location

Geisinger Wyoming Valley Medical Center

Wilkes-Barre, Pennsylvania, 18711, United States

Location

MeSH Terms

Conditions

Sick Sinus Syndrome; Bradycardia; Atrioventricular Block

Condition Hierarchy (Ancestors)

Arrhythmia, Sinus; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Heart Block; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2024
• First Posted: August 6, 2024
• Study Start: December 18, 2024
• Primary Completion: September 18, 2025
• Study Completion: June 1, 2026
• Last Updated: March 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The data will be available beginning no later than 12 months and ending 3 years after study completion.
• 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.

Locations

US (10)