Trials / Active Not Recruiting
Active Not RecruitingNCT06540079
BIOTRONIK Conduction System Pacing With the Solia Lead - Solia CSP S
BIOTRONIK Conduction System Pacing With the Solia Lead
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 192 (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 CSP S pacing lead when implanted in the left bundle branch area (LBBA). 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 CSP S lead | The Solia CSP S pacing lead will be implanted in the LBBA for patients who meet all inclusion/exclusion criteria and give written informed consent. |
Timeline
- Start date
- 2024-12-18
- Primary completion
- 2025-09-18
- Completion
- 2026-06-01
- First posted
- 2024-08-06
- Last updated
- 2026-03-11
Locations
10 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06540079. Inclusion in this directory is not an endorsement.