RecruitingNot ApplicableNCT06973031

A Prospective Clinical Study to Evaluate the Safety and Effectiveness of Pulmonary Vein Isolation Plus Box Isolation of Fibrotic Areas With the Globe® Pulsed Field System for Treating Patients With Symptomatic Paroxysmal or Persistent Atrial Fibrillation


Sponsor

Kardium Inc.

Enrollment

115 participants

Start Date

Jun 10, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The study will evaluate the safety and 12-month effectiveness of the Pulmonary Vein Isolation plus Box Isolation of Fibrotic Areas (BIFA) ablation strategy with the Globe Pulsed Field System (Globe PF System) for the treatment of atrial fibrillation.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new technology — the Globe Pulsed Field System — for treating atrial fibrillation (an irregular heartbeat) using a type of energy called pulsed field ablation, which targets and destroys the heart tissue causing the abnormal rhythm. **You may be eligible if...** - You have been diagnosed with paroxysmal (comes and goes) or persistent atrial fibrillation with recurring symptoms - At least one anti-arrhythmic medication has not worked or caused side effects **You may NOT be eligible if...** - You have had atrial fibrillation continuously for more than 12 months - Your atrial fibrillation is caused by something reversible (e.g., thyroid disease, recent surgery) - You had a stroke or blood clot event in the past 6 months - You had a heart attack, stent, or cardiac surgery in the last 3–6 months - You have had a previous ablation or surgery on the left side of your heart - You have a pacemaker or other implanted heart device - Your BMI is over 40 or your heart pumping function is significantly reduced 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 Pulsed Field System

Ablation and atrial mapping with the Globe Pulsed Field System


Locations(1)

Westpfalz-Klinikum GmbH Kaiserslautern

Kaiserslautern, Germany

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NCT06973031


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