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BIOTRONIK Conduction System Pacing With the Solia Lead - Solia CSP S
Sponsor: Biotronik, Inc.
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.
Official title: BIOTRONIK Conduction System Pacing With the Solia Lead
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
192
Start Date
2024-12-18
Completion Date
2026-06
Last Updated
2026-03-11
Healthy Volunteers
No
Interventions
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.
Locations (10)
Banner - University Medical Center Phoenix
Phoenix, Arizona, United States
Cardiology Associates Medical Group
Ventura, California, United States
Sarasota Memorial Hospital
Sarasota, Florida, United States
University of Chicago
Chicago, Illinois, United States
Cardiology Associates Research, LLC
Tupelo, Mississippi, United States
NYU Heart Rhythm Center
New York, New York, United States
Weill Cornell Medicine
New York, New York, United States
Atrium Health Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States
Cardiology Consultants of Philadelphia
Paoli, Pennsylvania, United States
Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, United States