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Active Not RecruitingNANCT06540079

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 assess...

Lead sponsor: Biotronik, Inc.•10 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Biotronik, Inc.

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Patient is a candidate for implantation of a BIOTRONIK pacemaker system, per standard guidelines. Single chamber, dual chamber, and CRT-P systems are allowed.
•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 meets a standard contraindication for pacemaker system implant
•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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: March 11, 2026Terms

Trial snapshot

StatusACTIVE_NOT_RECRUITING

PhaseNA

Enrollment192

Start dateDec 2024

Last updatedMar 11, 2026

Condition

Sinus Node Dysfunction Bradycardia Atrioventricular Block

Locations shown

Banner - University Medical Center Phoenix

Phoenix, Arizona

Cardiology Associates Medical Group

Ventura, California

Sarasota Memorial Hospital

Sarasota, Florida

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 11, 2026Data synced to Clareo: May 10, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions