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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months post implant
Awards & highlights

BIO-CONDUCT Trial 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.Check my eligibility
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.See study design
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.

BIO-CONDUCT Trial 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.

BIO-CONDUCT Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Implant Success rate of the Solia S lead in LBB area
Serious adverse device effect (SADE)-free rate at 3 months
Secondary outcome measures
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

BIO-CONDUCT Trial Design

1Treatment groups
Experimental Treatment
Group I: Solia S LBB leadExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Biotronik, Inc.Lead Sponsor
38 Previous Clinical Trials
54,563 Total Patients Enrolled

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an open enrollment period for this clinical research?

"As per records hosted on clinicaltrials.gov, recruitment for this medical study is ongoing and has been since the 12th of December 2022. The most recent update was posted on June 15th 2023."

Answered by AI

How many distinct sites are currently managing this clinical experiment?

"NYU Heart Rhythm Center in New york, Cardiology Associates in Tupelo and Cardiology Associates Medical Group in Ventura are three of the eight sites currently enrolling patients for this study. The other five medical locations remain undisclosed."

Answered by AI

What ambitions does this experiment seek to realize?

"The primary goal of the procedure and subsequent follow up will be to observe the Serious Adverse Device Effect (SADE)-free rate at 3 months. Secondary objectives encompass SADE-free rates 12 months post-implant, R-wave sensing amplitude measurements for Solia S leads implanted in the LBB area at both 3 and 6 month checkups, as well as any serious lead related or implant related device effects associated with Solia S leads."

Answered by AI

How many participants have been enlisted to participate in this clinical trial?

"Biotronik, Inc. are the sponsors of this medical trial and require 260 patients that fit its inclusion criteria to move forward. NYU Heart Rhythm Center in New york City and Cardiology Associates from Tupelo, Mississippi have been identified as two of the sites where data will be collected."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
BIOTRONIK Conduction System Pacing With the Solia Lead
2022. "BIOTRONIK Conduction System Pacing With the Solia Lead". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05251363.
All > Cardiomyopathy
~80 spots leftby Apr 2025
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