RecruitingNot ApplicableNCT05164107

Safety and Performance of a Pulsed Field Device for Global Mapping and Ablation of the Left Atrium for the Treatment of Atrial Fibrillation

PULSE-EU - A Prospective, Non-Randomized Clinical Pilot Study to Assess Safety and Performance of a Pulsed Field Device for Global Mapping and Ablation of the Left Atrium for the Treatment of Atrial Fibrillation


Sponsor

Kardium Inc.

Enrollment

175 participants

Start Date

Dec 8, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to provide clinical data pertaining to the safety and performance of the Globe Mapping and Pulsed Field Ablation System for treating subjects with atrial fibrillation (AF).


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a new device that uses pulsed field energy (not heat or cold, but brief electric pulses) to map and treat the heart in people with atrial fibrillation (AF) — an irregular heartbeat. The goal is to assess how safe and effective this new approach is. **You may be eligible if...** - You are 18–75 years old - You have a confirmed diagnosis of atrial fibrillation (within the last 12 months) - You are scheduled for a catheter ablation procedure to treat AF - You may have had one previous ablation (cryoablation, radiofrequency, or pulsed field) **You may NOT be eligible if...** - You have had multiple previous ablations in the heart's upper chambers - You are awaiting or have received a heart transplant - You have had a stroke or serious blood clot - You have moderate-to-severe heart failure (NYHA class III or IV) - You have a serious bleeding disorder or serious heart valve problems - You had a heart attack in the last 3 months - You have a device or implant that could interfere with the procedure (e.g., a device closing a hole in the heart) Talk to your doctor to see if this trial is right for you.

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

DEVICEGlobe Mapping and Pulsed Field Ablation System (Globe PF System)

During the procedure, the Globe Catheter will be delivered via standard femoral vein access and transseptal puncture. Anatomical and electrophysiological mapping of the left atrium (LA) will be followed by pulsed field ablation (PFA) to achieve pulmonary vein isolation (PVI). Additional PFA or radiofrequency (RF) ablation lesions may be created as deemed appropriate by the Investigator. Intracardiac electrogram mapping with the Globe PF System will be used to confirm PVI.


Locations(1)

Motol and Homolka University Hospital

Prague, Czechia

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NCT05164107


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