NCT05251363 (BIO-CONDUCT) is a NA clinical trial of Solia S lead in Bradycardia, sponsored by Biotronik, Inc..

Who is sponsoring NCT05251363?

NCT05251363 is sponsored by Biotronik, Inc..

What drugs are being tested in NCT05251363?

Interventions in NCT05251363: Solia S lead.

What condition does NCT05251363 study?

NCT05251363 studies Bradycardia, Atrioventricular Block, Left Bundle-Branch Block, Cardiomyopathies.

Is NCT05251363 still recruiting?

NCT05251363 is currently completed. Last updated 18 March 2025.

Are results published for NCT05251363?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-03-18 · How we verify

NCT05251363: BIO-CONDUCT

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

BIOTRONIK Conduction System Pacing With the Solia Lead

Completed NA Results posted Last updated 18 March 2025

What this trial tests

NA trial testing Solia S lead in Bradycardia in 194 participants. Completed in 8 October 2024.

Timeline

12 December 2022

Primary endpoint
9 January 2024

8 October 2024

Quick facts

Lead sponsor	Biotronik, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	194
Start date	12 December 2022
Primary completion	9 January 2024
Estimated completion	8 October 2024
Sites	14 locations across United States

Drugs / interventions tested

Solia S lead

Conditions studied

Bradycardia — all drugs for Bradycardia →
Atrioventricular Block — all drugs for Atrioventricular Block →
Left Bundle-Branch Block — all drugs for Left Bundle-Branch Block →
Cardiomyopathies — all drugs for Cardiomyopathies →

Sponsor

Biotronik, Inc. — full company profile →

Who can join

18 and older, any sex, with Bradycardia or Atrioventricular Block. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Serious Adverse Device Effect (SADE)-Free Rate at 3 Months Primary · 3 months post implant

The overall rate of serious Solia S Left Bundle Branch (LBB) lead related adverse device effects and serious implant procedure events related to the Solia S LBB lead that occur through 3 months post-implant. The definition of adverse device effect is an untoward medical occurrence (e.g. disease, injury) related to the use of a study device. Pacemaker lead-related examples include events such as lead dislodgements or lead malfunction. The Solia S LBB lead complication-free rate is calculated as the number of subjects without one or more adverse device effect complications divided by the total n

Group	Value	95% CI
Intent-to-treat (ITT) - Primary Endpoint 1	98	95.4 – 99.3

Implant Success Rate of the Solia S Lead in LBB Area Primary · at implant procedure

The percentage of subjects with Solia S placed successfully in the LBBA divided by the total number of consented study subjects in whom an implant of Solia S in the LBBA was attempted.

Group	Value	95% CI
Intent-to-Treat (ITT) - Primary Endpoint 2 (Efficacy)	95.7	91.7 – 98.1

Quality of Life (QOL) From Baseline Through 12 Months Post-Implant Secondary · 12 months post implant

The change in the physical function Short Form-36 (SF-36, 36-Item Short Form Health Survey) QOL subscale was calculated as the mean change from baseline to 12-month follow-up for all subjects that completed both the baseline QOL and 12-month QOL questionnaire. The physical function subscale of Short Form-36 is comprised of ten questions out of the total of 36 questions. The responses to the ten questions relating to physical function were averaged at baseline and at 12 months. The difference in the averages (12 months minus baseline) is reported as the outcome for secondary endpoint 1. Note th

Group	Value	95% CI
Intent-to-Treat (ITT) - Secondary Endpoint 1 (QOL)	11.4	7.4 – 15.4

Serious Adverse Device Effect (SADE)-Free Rate at 6 Months Secondary · 6 months post implant

The overall rate of serious Solia S LBBA lead related adverse device effects and serious implant procedure events related to the Solia S LBBA lead that occur through 6 months post-implant. The Solia S LBBA lead complication-free rate per subject, which was calculated as the number of subjects without one or more complications divided by the total number of study subjects successfully enrolled and subjects undergoing an unsuccessful implant attempt who have a qualifying safety endpoint event. The complication-free rate is expressed in percentage of participants without SADE.

Group	Value	95% CI
Intent-to-Treat (ITT) - Secondary Endpoint 2 (SADE-Free Rate at 6-Mo)	96.7	93.7 – 98.6

Serious Adverse Device Effect (SADE)-Free Rate at 12 Months Secondary · 12 months post implant

The overall rate of serious Solia S LBBA lead related adverse device effects and serious implant procedure events related to the Solia S LBBA lead that occur through 12 months post-implant. The Solia S LBBA lead complication-free rate per subject, which was calculated as the number of subjects without one or more complications divided by the total number of study subjects successfully enrolled and subjects undergoing an unsuccessful implant attempt who have a qualifying safety endpoint event. The complication-free rate is expressed in percent.

Group	Value	95% CI
Intent-to-Treat (ITT) - Secondary Endpoint 2 (SADE-Free Rate at 12-Mo)	96.1	92.6 – 98.2

Pacing Threshold Measurements for Solia S Lead at 3 Months Secondary · 3 months post implant

Pacing threshold measurements for Solia S leads implanted in the LBBA at the 3 month follow-up visit.

Group	Value	95% CI
Intent-to-Treat (ITT) - Secondary Endpoint 3 (Pacing Threshold at 3-Mo)	0.94	± 0.26

Sensing Measurements for Solia S Lead at 3 Months Secondary · 3 months post implant

R-wave sensing amplitude measurements for Solia S leads implanted in the LBBA at the 3 month follow-up visit.

Group	Value	95% CI
Intent-to-Treat (ITT) - Secondary Endpoint 4 (R-wave Sensed Amplitude at 3-Mo)	12.37	± 4.16

Pacing Impedance for Solia S Lead at 3 Months Secondary · 3 months post implant

Pacing impedance measurements for Solia S leads implanted in the LBBA at the 3 month follow-up visit.

Group	Value	95% CI
Intent-to-Treat (ITT) - Secondary Endpoint 5 (Pacing Impedance at 3-Mo)	540.4	± 96.4

Pacing Threshold Measurements for Solia S Lead at 6 Months Secondary · 6 months post implant

Pacing threshold measurements for Solia S leads implanted in the LBBA at the 6 month follow-up visit.

Group	Value	95% CI
Intent-to-Treat (ITT) - Secondary Endpoint 3 (Pacing Threshold at 6-Mo)	0.97	± 0.27

Sensing Measurements for Solia S Lead at 6 Months Secondary · 6 months post implant

R-wave sensing amplitude measurements for Solia S leads implanted in the LBBA at the 6 month follow-up visit.

Group	Value	95% CI
Intent-to-Treat (ITT) - Secondary Endpoint 4 (R-wave Sensed Amplitude at 6-Mo)	12.83	± 4.78

Pacing Impedance for Solia S Lead at 6 Months Secondary · 6 months post implant

Pacing impedance measurements for Solia S leads implanted in the LBBA at the 6 month follow-up visit.

Group	Value	95% CI
Intent-to-Treat (ITT) - Secondary Endpoint 5 (Pacing Impedance at 6-Mo)	526.7	± 96.7

Pacing Threshold Measurements for Solia S Lead at 12 Months Secondary · 12 months post implant

Pacing threshold measurements for Solia S leads implanted in the LBBA at the 12 month follow-up visit.

Group	Value	95% CI
Intent-to-Treat (ITT) - Secondary Endpoint 3 (Pacing Threshold at 12-Mo)	0.98	± 0.29

Adverse events — posted to ClinicalTrials.gov

Time frame: Overall study duration of 12 months: from implant (or implant attempt) through each subject's exit date. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Subjects With a Successful Solia S Implant or Unsuccessful Implant Attempt in the LBBA

Serious: 52/186 (28%)

Deaths: 9/186

Serious adverse events (23 terms)

Reaction	System	Subjects With a Successful…
Not Implanted System or Procedure Related - Cardiac Disorders	Cardiac disorders	—
Not Implanted System or Procedure Related - Respiratory, Thoracic, and Mediastinal Disorders	Respiratory, thoracic and mediastinal disorders	—
Not Implanted System or Procedure Related - Surgical and Medical Procedures	Surgical and medical procedures	—
Not Implanted System or Procedure Related - Infections and Infestations	Infections and infestations	—
Not Implanted System or Procedure Related - General Disorders	General disorders	—
Not Implanted System or Procedure Related - Renal and Urinary Disorders	Renal and urinary disorders	—
Other Implanted System Related - RA Lead Dislodgement	Product Issues	—
Not Implanted System or Procedure Related - Vascular Disorders	Vascular disorders	—
Solia S LBBA Lead Related - Lead Dislodgement	Product Issues	—
Not Implanted System or Procedure Related - Gastrointestinal Disorders	Gastrointestinal disorders	—
Not Implanted System or Procedure Related - Neoplasms Benign, Malignant, and Unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
Not Implanted System or Procedure Related - Hepatobiliary Disorders	Hepatobiliary disorders	—
Not Implanted System or Procedure Related - Nervous System Disorders	Nervous system disorders	—
Not Implanted System or Procedure Related - Injury, Poisoning and Procedural Complications	Injury, poisoning and procedural complications	—
Procedure Related - Other Implant Procedure Related Adverse Event	Surgical and medical procedures	—
Procedure Related - Deep Vein Thrombosis	Vascular disorders	—
Procedure Related - Infection	Infections and infestations	—
Procedure Related - Hospital Admission for any Reason Attributable to Implant Procedure	Surgical and medical procedures	—
Procedure Related - Pneumo or Hemothorax Associated with Implant Procedure	Injury, poisoning and procedural complications	—
Other Implanted System Related - Other Unexpected Complication Related to RA Lead	Product Issues	—
Other Implanted System Related - Other Pulse Generator Related Adverse Event	Product Issues	—
Other Implanted System Related - Abnormal RA Lead Performance	Product Issues	—
Not Implanted System or Procedure Related - Blood and Lymphatic System Disorders	Blood and lymphatic system disorders	—

Most-reported serious reactions: Not Implanted System or Procedure Related - Cardiac Disorders, Not Implanted System or Procedure Related - Respiratory, Thoracic, and Mediastinal Disorders, Not Implanted System or Procedure Related - Surgical and Medical Procedures, Not Implanted System or Procedure Related - Infections and Infestations, Not Implanted System or Procedure Related - General Disorders, Not Implanted System or Procedure Related - Renal and Urinary Disorders, Other Implanted System Related - RA Lead Dislodgement, Not Implanted System or Procedure Related - Vascular Disorders.

Data from ClinicalTrials.gov NCT05251363 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Bradycardia

Currently open trials in the same condition.

NCT07209852 — Safety, Performance, and Clinical Benefit of Pacing the Left Bundle Branch Area - Post-Market Clinical Follow-up · recruiting
NCT07254013 — Left Bundle Branch Area Pacing (LBBAP) Monitoring Assistant: Evaluation of Portable ECG Solution · NA · recruiting
NCT07166614 — Dexmedetomidine vs Propofol in High-Risk ERCP Patients · NA · recruiting
NCT07585799 — Permanent Conduction System Pacing Versus Atrioventricular Management for Patients With Wide QRS and Patent AV Conductio · NA · recruiting
NCT07217392 — Left Bundle Branch Area Pacing (LBBAP) PMCF Study · NA · recruiting

Other Biotronik, Inc. trials

Trials by the same sponsor.

NCT04870281 — Atrial Fibrillation Associated With Heart Failure Treated by BIOTRONIK's CRT-DX System · terminated
NCT04175626 — Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions · completed
NCT04076917 — Assessment of the Utility of BIOMONITOR to Identify Atrial Fibrillation (AF) in Ablation Candidates Using Precise AF Det · terminated
NCT03884608 — Analysis of Both Sex and Device Specific Factors on Outcomes in Patients with Non-Ischemic Cardiomyopathy · completed
NCT03594266 — Comparison of the Effects of Two Spinal Cord Stimulation (SCS) Therapies on Subject Reported Pain (BENEFIT-02) · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05251363 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Biotronik, Inc.
Last refreshed: 18 March 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05251363.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing