At a glance
ClinicalIndex Comparison RecordN/ACompleted· 194 enrolled
Drug / intervention
Solia S leaddevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
BIOTRONIK Conduction System Pacing With the Solia Lead
In Brief
A clinical study evaluating Solia S lead for Bradycardia and 3 related conditions. Completed, enrolled 194 participants across 14 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
2023202420252026
First PostedFeb 2022
Enrollment StartDec 2022
Primary CompletionJan 2024
Study CompletionOct 2024
TodayJul 2026
First PostedFeb 22, 2022
Enrollment StartDec 12, 2022
Primary CompletionJan 9, 2024
Study CompletionOct 8, 2024
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 4.4 years ago
Interventions
Solia S leaddevice
The Solia S pacing lead will be implanted in the LBB area for patients who meet all inclusion/exclusion criteria and give written informed consent.