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BIOTRONIK Conduction System Pacing With the Solia Lead

NCT05251363 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 194

Last updated 2025-03-18

Study results available
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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.

Conditions

  • Bradycardia
  • Atrioventricular Block
  • Left Bundle-Branch Block
  • Cardiomyopathies

Interventions

DEVICE

Solia S lead

The Solia S pacing lead will be implanted in the LBB area for patients who meet all inclusion/exclusion criteria and give written informed consent.

Sponsors & Collaborators

  • Biotronik, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-12
Primary Completion
2024-01-09
Completion
2024-10-08
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05251363 on ClinicalTrials.gov