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Conduction System Pacing

Solia Lead for Left Bundle Branch Block (BIO-CONDUCT Trial)

N/A
Waitlist Available
Research Sponsored by Biotronik, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient is a candidate for implantation of a BIOTRONIK pacemaker system, per standard guidelines. Single chamber, dual chamber, and CRT-P systems are allowed.
Be older than 18 years old
Must not have
Patient has planned cardiac surgical procedures or interventional measures within 3 months after implant
Patient has the presence of another life-threatening, underlying illness separate from their cardiac disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months post implant
Awards & highlights
No Placebo-Only Group

Summary

This trialis testing a heart device to make sure it is safe & effective when implanted in the left bundle branch. Results will be measured for 3 months post-implant.

Who is the study for?
This trial is for adults over 18 who need a BIOTRONIK pacemaker and are getting left bundle branch area pacing. They must understand the study, consent to it, agree to regular follow-ups, accept Home Monitoring®, and not have standard contraindications for pacemaker implant.
What is being tested?
The BIO-CONDUCT study tests the safety and effectiveness of the Solia S lead when implanted in the left bundle branch area. Success rates will be measured by serious adverse device effects within three months post-implant.
What are the potential side effects?
Potential side effects may include complications related to device implantation such as infection at the site of surgery, bleeding or bruising, lead displacement or malfunctioning which could affect heart rhythm.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am eligible for a BIOTRONIK pacemaker implant according to standard guidelines.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am scheduled for a heart surgery or procedure within the next 3 months.
Select...
I have a serious illness in addition to my heart condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months post implant
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months post implant for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Implant Success rate of the Solia S lead in LBB area
Serious adverse device effect (SADE)-free rate at 3 months
Secondary study objectives
Pacing impedance for Solia S lead at 12 months
Pacing impedance for Solia S lead at 3 months
Pacing impedance for Solia S lead at 6 months
+9 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Solia S LBB leadExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Solia S lead
2022
N/A
~190

Find a Location

Who is running the clinical trial?

Biotronik, Inc.Lead Sponsor
39 Previous Clinical Trials
54,673 Total Patients Enrolled
1 Trials studying Atrioventricular Block
110 Patients Enrolled for Atrioventricular Block

Media Library

Solia S lead (Conduction System Pacing) Clinical Trial Eligibility Overview. Trial Name: NCT05251363 — N/A
Atrioventricular Block Research Study Groups: Solia S LBB lead
Atrioventricular Block Clinical Trial 2023: Solia S lead Highlights & Side Effects. Trial Name: NCT05251363 — N/A
Solia S lead (Conduction System Pacing) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05251363 — N/A
~60 spots leftby Jan 2026
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