BIOTRONIK Conduction System Pacing With the Solia Lead

NCT05251363 | Completed Results FDA Device

• 1 other identifier: G210349
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 14

Brief Summary

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.

Conditions

Bradycardia; Atrioventricular Block; Left Bundle-Branch Block; Cardiomyopathies

Outcome Measures

Primary Outcomes (2)

• 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 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 for Solia S Lead at 3 Months

  3 months post implant

• Sensing Measurements for Solia S Lead at 3 Months

  3 months post implant

Study Arms (1)

Solia S LBB lead

OTHER

Device: Solia S lead

Interventions

Solia S lead DEVICE

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.

Solia 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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biotronik, Inc.: lead

Study Sites (14)

Banner - University Medical Center Phoenix

Phoenix, Arizona, 85006, United States

Location

Cardiology Associates Medical Group

Ventura, California, 93003, United States

Location

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Sarasota Memorial Health Care System

Sarasota, Florida, 34239, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Cardiology Associates

Tupelo, Mississippi, 38801, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

Weill Cornell Medicine

New York, New York, 10021, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Cardiology Consultants of Philadelphia

Philadelphia, Pennsylvania, 19107, United States

Location

Geisinger

Wilkes-Barre, Pennsylvania, 18711, United States

Location

Medical University of South Carolina (MUSC)

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Bradycardia; Atrioventricular Block; Bundle-Branch Block; Cardiomyopathies

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Crystal Miller
• Organization: BIOTRONIK, Inc.

crystal.miller@biotronik.com

(503) 475-4984

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: February 7, 2022
• First Posted: February 22, 2022
• Study Start: December 12, 2022
• Primary Completion: January 9, 2024
• Study Completion: October 8, 2024
• Last Updated: March 18, 2025
• Results First Posted: March 18, 2025

Record last verified: 2025-02

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.
• 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 (14)