BIOTRONIK Conduction System Pacing With the Solia Lead - Solia CSP S
NCT ID: NCT06540079
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
220 participants
INTERVENTIONAL
2024-12-18
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Solia CSP S LBB Lead
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Patient has an implant planned to utilize left bundle branch area (LBBA) pacing within 30 days of consent
* Patient is able to understand the nature of the study and provide written informed consent
* Patient is available for follow-up visits on a regular basis for the expected duration of follow-up
* Patient accepts Home Monitoring® concept
* Patient age is greater than or equal to 18 years at time of consent
Exclusion Criteria
* Patient is currently implanted with a pacemaker or ICD device
* Patient has had a previous unsuccessful attempt to place a lead in the LBBA
* Patient has planned cardiac surgical procedures or interventional measures within 3 months after implant
* Patient is expected to receive a heart transplant within 12 months
* Patient life expectancy less than 12 months
* Patient has the presence of another life-threatening, underlying illness separate from their cardiac disorder
* Patient reports pregnancy at the time of enrollment
* Patient is enrolled in any other investigational cardiac clinical study during the course of the study
18 Years
ALL
No
Sponsors
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Biotronik, Inc.
INDUSTRY
Responsible Party
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Locations
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Banner - University Medical Center Phoenix
Phoenix, Arizona, United States
Cardiology Associates Medical Group
Ventura, California, United States
Sarasota Memorial Hospital
Sarasota, Florida, United States
University of Chicago
Chicago, Illinois, United States
Cardiology Associates Research, LLC
Tupelo, Mississippi, United States
NYU Heart Rhythm Center
New York, New York, United States
Weill Cornell Medicine
New York, New York, United States
Atrium Health Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States
Cardiology Consultants of Philadelphia
Paoli, Pennsylvania, United States
Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, United States
Countries
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Central Contacts
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Other Identifiers
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G210349-Solia CSP S
Identifier Type: -
Identifier Source: org_study_id