N/A
N=186
BIOTRONIK Conduction System Pacing With the Solia Lead
Bradycardia · Atrioventricular Block · Left Bundle-Branch Block · Cardiomyopathies
Bottom Line
View on ClinicalTrials.gov: NCT05251363 ↗Enrolled (actual)
186
Serious AEs
28.0%
Results posted
Mar 2025
Primary outcome: Primary: Serious Adverse Device Effect (SADE)-Free Rate at 3 Months — 98 Percentage of participants without SADE — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Solia S lead (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Biotronik, Inc.
- Primary completion
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Serious Adverse Device Effect (SADE)-Free Rate at 3 Months |
98 | <0.0001 sig |
| PRIMARY Implant Success Rate of the Solia S Lead in LBB Area |
95.7 | < 0.0001 sig |
| SECONDARY Quality of Life (QOL) From Baseline Through 12 Months Post-Implant |
11.4 | <0.001 sig |
| SECONDARY Serious Adverse Device Effect (SADE)-Free Rate at 6 Months |
96.7 | — |
| SECONDARY Serious Adverse Device Effect (SADE)-Free Rate at 12 Months |
96.1 | — |
| SECONDARY Pacing Threshold Measurements for Solia S Lead at 3 Months |
0.94 | — |
| SECONDARY Sensing Measurements for Solia S Lead at 3 Months |
12.37 | — |
| SECONDARY Pacing Impedance for Solia S Lead at 3 Months |
540.4 | — |
| SECONDARY Pacing Threshold Measurements for Solia S Lead at 6 Months |
0.97 | — |
| SECONDARY Sensing Measurements for Solia S Lead at 6 Months |
12.83 | — |
| SECONDARY Pacing Impedance for Solia S Lead at 6 Months |
526.7 | — |
| SECONDARY Pacing Threshold Measurements for Solia S Lead at 12 Months |
0.98 | — |
| SECONDARY Sensing Measurements for Solia S Lead at 12 Months |
12.76 | — |
| SECONDARY Pacing Impedance for Solia S Lead at 12 Months |
521.8 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT05251363). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.