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ACTIVE NOT RECRUITING
NCT06540079
NA

BIOTRONIK Conduction System Pacing With the Solia Lead - Solia CSP S

Sponsor: Biotronik, Inc.

View on ClinicalTrials.gov

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.

Official title: BIOTRONIK Conduction System Pacing With the Solia Lead

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

192

Start Date

2024-12-18

Completion Date

2026-06

Last Updated

2026-03-11

Healthy Volunteers

No

Interventions

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.

Locations (10)

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