Status:
RECRUITING
BIOTRONIK Conduction System Pacing With the Solia Lead - Solia CSP S
Lead Sponsor:
Biotronik, Inc.
Conditions:
Sinus Node Dysfunction
Bradycardia
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 CSP S pacing lead when implanted in the left bundle branch area (LBBA). Safety will be assess...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
December 18 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT06540079
Start Date
December 18 2024
End Date
June 1 2026
Last Update
December 15 2025
Active Locations (10)
Enter a location and click search to find clinical trials sorted by distance.
1
Banner - University Medical Center Phoenix
Phoenix, Arizona, United States, 85006
2
Cardiology Associates Medical Group
Ventura, California, United States, 93003
3
Sarasota Memorial Hospital
Sarasota, Florida, United States, 34239
4
University of Chicago
Chicago, Illinois, United States, 60637