BIOTRONIK Conduction System Pacing With the Solia Lead

Completed · Not applicable

Conditions studied: Bradycardia, Atrioventricular Block, Left Bundle-Branch Block, Cardiomyopathies

In brief

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.

Key facts

Study ID

NCT05251363

Run by

Biotronik, Inc.

People needed

194

Starts

2022-12-12

Expected to finish

2024-10-08

Last updated by the study team

2025-03-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Banner - University Medical Center Phoenix — Phoenix, Arizona, United States
• Cardiology Associates Medical Group — Ventura, California, United States
• Washington Hospital Center — Washington D.C., District of Columbia, United States
• Sarasota Memorial Health Care System — Sarasota, Florida, United States
• Tampa General Hospital — Tampa, Florida, United States
• Rush University Medical Center — Chicago, Illinois, United States
• University of Chicago — Chicago, Illinois, United States
• Cardiology Associates — Tupelo, Mississippi, United States
• NYU Langone Health — New York, New York, United States
• Weill Cornell Medicine — New York, New York, United States
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
• Cardiology Consultants of Philadelphia — Philadelphia, Pennsylvania, United States
• Geisinger — Wilkes-Barre, Pennsylvania, United States
• Medical University of South Carolina (MUSC) — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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