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ACTIVE NOT RECRUITING
NCT07287423
NA

LEAP 2 Chronic EFS

Sponsor: Abbott Medical Devices

View on ClinicalTrials.gov

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.

Official title: LEadless Advanced Pacing 2 Chronic Early Feasibility Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2025-12-13

Completion Date

2028-12

Last Updated

2026-03-27

Healthy Volunteers

No

Interventions

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.

Locations (1)

Nemocnice Na Homolce

Prague, Czechia