Trials / Completed
CompletedNCT05251363
BIOTRONIK Conduction System Pacing With the Solia Lead
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 194 (actual)
- Sponsor
- Biotronik, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Solia S lead | 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. |
Timeline
- Start date
- 2022-12-12
- Primary completion
- 2024-01-09
- Completion
- 2024-10-08
- First posted
- 2022-02-22
- Last updated
- 2025-03-18
- Results posted
- 2025-03-18
Locations
14 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05251363. Inclusion in this directory is not an endorsement.