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.

UMIN ID: UMIN000056191

Registered date:19/11/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Atrioventricular block
• Date of first enrollment: 2024/11/19
• Target sample size: 80
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Intervention group: contenuous pacig method. Intervention duration: during pacemaker implantation Number of interventions: once Frequency: once
Control group: conventional method. Intervention duration: during pacemaker implantation Number of interventions: once Frequency: once

Outcome(s)

• Primary Outcome: Acute procedure success: Percentage of patients achieving sucsessful left bandle branch area pacing.

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: Other
• Source(s) of Monetary Support: Other