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NCT06540079 · ClinicalTrials.gov registry record · NA
BIOTRONIK Conduction System Pacing With the Solia Lead - Solia CSP S
A NA study of Bradycardia and Atrioventricular Block, sponsored by Biotronik.
- Active
- Registry status
- NA
- Development phase
- 192
- Enrollment target
- 10
- Study locations
NCT06540079: Active NA study of Bradycardia and Atrioventricular Block, sponsored by Biotronik.
NCT06540079 is a NA study of Bradycardia and Atrioventricular Block that is active but no longer recruiting, run by Biotronik. The registered enrollment target is 192 participants, below the 4,406-participant average among 29 other Bradycardia trials with a reported enrollment target (96% lower). The trial reports 10 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06540079, a NA study of Bradycardia and Atrioventricular Block, is active but no longer recruiting, sponsored by Biotronik.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 192 participants
- Enrollment target
- 10
- Study locations
Study 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.
Primary Outcome
Serious adverse device effect includes both serious lead related and serious implant related device effects. The overall percentage of subjects without serious lead related adverse device effects related to Solia CSP S lead utilized or attempted to be implanted in the LBBA and serious implant procedure events related to the Solia CSP S LBBA lead will be reported.
Conditions Studied
Interventions
- DEVICE Solia CSP S lead
Study Locations (10)
New York
- NYU Heart Rhythm Center - New York
- Weill Cornell Medicine - New York
Pennsylvania
- Cardiology Consultants of Philadelphia - Paoli
- Geisinger Wyoming Valley Medical Center - Wilkes-Barre
Arizona
- Banner - University Medical Center Phoenix - Phoenix
California
- Cardiology Associates Medical Group - Ventura
Florida
- Sarasota Memorial Hospital - Sarasota
Illinois
- University of Chicago - Chicago
Mississippi
- Cardiology Associates Research, LLC - Tupelo
North Carolina
- Atrium Health Wake Forest Baptist Medical Center - Winston-Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 192 participants |
| Start Date | 2024-12-18 |
| Est. Completion | 2026-06 |
| Phase | NA |
What the registry record for NCT06540079 still lists
NCT06540079 is an interventional study that assigns participants to a tested intervention. The registered 192 participants enrollment target is mid-sized for trials with a published cap, below the 4,406-participant average among 29 other Bradycardia trials with a reported enrollment target (96% lower).
The record links to 3 conditions, with Bradycardia appearing as the primary indexed condition, and to 1 intervention - of which Solia CSP S lead is the first listed.
NCT06540079 lists 10 locations in 8 states (New York, Pennsylvania, Arizona).
Frequently Asked Questions
What is clinical trial NCT06540079 about?
NCT06540079 is a clinical study titled "BIOTRONIK Conduction System Pacing With the Solia Lead - Solia CSP S". 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 w...
What is the current status of trial NCT06540079?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 192 participants. The study started on 2024-12-18. Estimated completion is 2026-06.
What conditions does trial NCT06540079 study?
This clinical trial studies the following conditions: Bradycardia, Atrioventricular Block, Sinus Node Dysfunction.
What interventions are being tested in trial NCT06540079?
The interventions under investigation include: Solia CSP S lead (DEVICE).
Who is sponsoring clinical trial NCT06540079?
This trial is sponsored by Biotronik, which has 30 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06540079 being conducted?
This trial has 10 study locations across Arizona, California, Florida, Illinois, Mississippi. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06540079's enrollment target sits among peer trials
192 23rd of 29 higher than 7 of 29 other Bradycardia trials
participants (enrollment target), bucketed by value
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