NCT06690333

Efficacy and Safety of Leadless Pacemakers Versus Left Bundle Area Pacing - A Preliminary Exploration

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: NCH Healthcare System, Inc. dba Naples Comprehensive Health and dba NCH · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, randomized controlled (1:1) multicenter trial. The pilot study will be conducted up to three clinical sites in the United States. The primary purpose of this study is to compare the overall safety and efficacy between the leadless pacemaker and left bundle area pacing.

Detailed description

This is a prospective, randomized controlled (1:1) multicenter trial. The pilot study will be conducted up to three clinical sites in the United States. This study is designed to compare the safety and effectiveness of two types of pacemaker treatments: leadless pacemakers and left bundle area pacing. Patients who's heart rhythm indicate a degree of heart block that slows the heart beat and decreases the amount of blood the heart is pumping to the rest of the body will be identified by physicians to participate. This study seeks to improve our understanding of heart rhythm disorders to allow us to provide the best treatment for our patients.

Conditions

• Pacemaker Implantation
• AV Node Disease

Interventions

Type	Name	Description
DEVICE	Pacemaker	Transvenous pacemaker with left bundle area pacing
DEVICE	Pacemaker	Transcatheter pacemaker with MICRA AV

Timeline

• Start date: 2024-11-05
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2024-11-15
• Last updated: 2025-05-30

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study