An Open-Label, Randomized Parallel-Group Non-Inferiority Trial Comparing the Efficacy and Safety of Implantation with Continuous Pacing Stimulation in Left Bundle Branch Area Pacing to Conventional Therapy.

An Open-Label, Randomized Parallel-Group Non-Inferiority Trial Comparing the Efficacy and Safety of Implantation with Continuous Pacing Stimulation in Left Bundle Branch Area Pacing to Conventional Therapy. - An Open-Label, Randomized Parallel-Group Non-Inferiority Trial Comparing the Efficacy and Safety of Implantation with Continuous Pacing Stimulation in Left Bundle Branch Area Pacing to Conventional Therapy.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000056191

Enrollment

Registered

2024-11-19

Start date

2024-11-19

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrioventricular block

Interventions

Intervention group: contenuous pacig method using a stylet-driven lead Intervention duration: during pacemaker implantation Number of interventions: once Frequency: once Control group: conventiona

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients are eligible for this study if they meet the following criteria. 1) Patients are older than 18 years. 2) Patients who required frequent ventricular pacing (>20%) due to bradyarrhythmia (atrioventricular block, bifascicular or trifascicular block, bradycardic atrial fibrillation).

Exclusion criteria

Exclusion criteria: 1) Patients who are not expected to have a ventricular pacing burden of > 20%. 2) Patients who are eligible for an implantable cardioverter defibrillator (ICD) or a cardioverter defibrillator with biventricular pacing function (CRT-D). 3) Patients who have difficulty with transvenous lead placement. 4) Patients who are allergic to contrast. 5) Patinets who are pregnant or may become pregnant, or who are breast-feeding. 6) Patients who are considererd inappropriate by the principal investigator.

Design outcomes

Primary

Measure	Time frame
Acute procedure success: Percentage of patients achieving sucsessful left bandle branch area pacing.	—

Countries

Japan

Contacts

Public ContactJunji Maeda

Hiroshima University Hospital Cardiology

jun2.shiningcrystal@gmail.com082-257-5540

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026