Status:
COMPLETED
BIOTRONIK Conduction System Pacing With the Solia Lead
Lead Sponsor:
Biotronik, Inc.
Conditions:
Bradycardia
Atrioventricular Block
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
December 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 8 2024
Estimated Enrollment :
194 Patients enrolled
Trial Details
Trial ID
NCT05251363
Start Date
December 12 2022
End Date
October 8 2024
Last Update
March 18 2025
Active Locations (14)
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1
Banner - University Medical Center Phoenix
Phoenix, Arizona, United States, 85006
2
Cardiology Associates Medical Group
Ventura, California, United States, 93003
3
Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
4
Sarasota Memorial Health Care System
Sarasota, Florida, United States, 34239