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NCT05251363 · ClinicalTrials.gov registry record · NA
BIOTRONIK Conduction System Pacing With the Solia Lead
A NA study, sponsored by Biotronik.
- Completed
- Registry status
- NA
- Development phase
- 194
- Enrollment target
NCT05251363: Completed NA study, sponsored by Biotronik.
NCT05251363 is a NA study that has completed, run by Biotronik. The registered enrollment target is 194 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05251363, a NA study, has completed, sponsored by Biotronik.
- COMPLETED
- Registry status
- NA
- Development phase
- 194 participants
- Enrollment target
Study 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.
Primary Outcome
The overall rate of serious Solia S Left Bundle Branch (LBB) lead related adverse device effects and serious implant procedure events related to the Solia S LBB lead that occur through 3 months post-implant. The definition of adverse device effect is an untoward medical occurrence (e.g. disease, injury) related to the use of a study device. Pacemaker lead-related examples include events such as lead dislodgements or lead malfunction. The Solia S LBB lead complication-free rate is calculated as t
Interventions
- DEVICE Solia S lead
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 194 participants |
| Start Date | 2022-12-12 |
| Est. Completion | 2024-10-08 |
| Phase | NA |
What the finished NCT05251363 record still lists
NCT05251363 is an interventional study that assigns participants to a tested intervention. The registered 194 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 1 intervention - of which Solia S lead is the first listed.
NCT05251363 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05251363 about?
NCT05251363 is a clinical study titled "BIOTRONIK Conduction System Pacing With the Solia Lead". 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 b...
What is the current status of trial NCT05251363?
This trial is currently completed. It is a NA study. The enrollment target is 194 participants. The study started on 2022-12-12. Estimated completion is 2024-10-08.
What interventions are being tested in trial NCT05251363?
The interventions under investigation include: Solia S lead (DEVICE).
Who is sponsoring clinical trial NCT05251363?
This trial is sponsored by Biotronik, which has 30 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05251363's enrollment target sits among peer trials
194 568th of 2000 higher than 1,432 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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