NCT07287423

LEAP 2 Chronic EFS

LEadless Advanced Pacing 2 Chronic Early Feasibility Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Prospective, single-arm, non-randomized, unblinded, chronic feasibility study designed to evaluate the safety and performance of the AVEIR™ Conduction System Pacing (CSP) Leadless Pacemaker system.

Detailed description

The purpose of this clinical investigation is to evaluate the chronic safety and performance of the AVEIR CSP Leadless Pacemaker system in a patient population with standard pacing indications. Subjects participating in the study will have data collected at baseline, implant procedure, pre (hospital) discharge, and follow-up at 1 month, 3 months, 6 months, 12 months, and every 6 months thereafter until study completion

Conditions

• Cardiac Pacemaker
• Cardiac Rhythm Disorder
• Bradycardia

Interventions

Type	Name	Description
DEVICE	AVEIR CSP Leadless Pacemaker System	Patients will undergo a single or dual-chamber leadless pacemaker system implant wherein an investigational AVEIR CSP leadless pacemaker will be implanted in the right ventricle. Then, a commercial AVEIR AR leadless pacemaker may optionally be co-implanted in the right atrium, if indicated.

Timeline

• Start date: 2025-12-13
• Primary completion: 2026-03-16
• Completion: 2028-12-01
• First posted: 2025-12-17
• Last updated: 2026-03-27

Locations

1 site across 1 country: Czechia

Regulatory

• FDA-regulated device study