RecruitingNot ApplicableNCT07287423

LEAP 2 Chronic EFS

LEadless Advanced Pacing 2 Chronic Early Feasibility Study

Sponsor

Abbott Medical Devices

Enrollment

30 participants

Start Date

Dec 13, 2025

Study Type

INTERVENTIONAL

Conditions

Cardiac Rhythm Disorder Bradycardia Cardiac Pacemaker

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called AVEIR CSP Leadless Pacemaker System for people with bradycardia, cardiac pacemaker, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEAVEIR 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

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NCT07287423

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