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BIOTRONIK Conduction System Pacing With the Solia Lead | Clinical Trials | Clareo Health

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BIOTRONIK Conduction System Pacing With the Solia Lead

NCT05251363•Biotronik, Inc.

Summary

The purpose of the BIO-CONDUCT study is to demonstrate the safety and effectiveness of the BIOTRONIK Solia S pacing lead when implanted in the left bundle branch (LBB) area. 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patient is a candidate for implantation of a BIOTRONIK pacemaker system, per standard guidelines. Single chamber, dual chamber, and Cardiac Resynchronization Therapy with a Pacemaker (CRT-P) systems are allowed.
•Patient has an implant planned to utilize left bundle branch area 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 Implantable Cardioverter-Defibrillator (ICD) device
•Patient has had a previous unsuccessful attempt to place a lead in the LBB area
•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

Locations (14)

Banner - University Medical Center Phoenix

Phoenix, Arizona, United States

Cardiology Associates Medical Group

Ventura, California, United States

Washington Hospital Center

Washington D.C., District of Columbia, United States

Sarasota Memorial Health Care System

Sarasota, Florida, United States

Tampa General Hospital

Tampa, Florida, United States

Rush University Medical Center

Chicago, Illinois, United States

University of Chicago

Chicago, Illinois, United States

Cardiology Associates

Tupelo, Mississippi, United States

NYU Langone Health

New York, New York, United States

Weill Cornell Medicine

New York, New York, United States

Key Dates

Start Date

December 12, 2022

Primary Completion Date

January 9, 2024

Completion Date

October 8, 2024

Last Updated

March 18, 2025

Enrollment

194

ACTUAL participants

Conditions

BradycardiaAtrioventricular BlockLeft Bundle-Branch BlockCardiomyopathies

Interventions

Solia S lead

DEVICE

Comparison of Supra vs Infra Inguinal Fascia Iliaca Blocks for Spinal Positioning and Analgesia in Lower Limb Surgery

NCT07221682

Post Operative AnalgesiaBradycardia+1 more

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RECRUITING

His Bundle Pacing in Bradycardia and Heart Failure

NCT03008291

BradycardiaHeart Failure

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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 18, 2025Data synced to Clareo: March 29, 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.

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BIOTRONIK Conduction System Pacing With the Solia Lead

Inclusion Criteria

Exclusion Criteria

Comparison of Supra vs Infra Inguinal Fascia Iliaca Blocks for Spinal Positioning and Analgesia in Lower Limb Surgery

His Bundle Pacing in Bradycardia and Heart Failure

Comparative Analysis Of Dexmedetomidine And Dexamethasone As An Adjuvant To 0.5%Ropivacaine On Onset Of Ultrasound Guided Supraclavicular Brachial Plexus Block In Patients Undergoing Upper Limb Surgeries

Left Bundle Branch Area Mapping for Conduction System Pacing

Trial Evaluating the Benefit of Left Bundle Branch Area Stimulation Compared With Conventional Pacing in Post-TAVI Atrioventricular Atrioventricular Block

Left Bundle Branch Area Pacing (LBBAP) Monitoring Assistant: Evaluation of Portable ECG Solution