Pulmonary vein isolation plus box isolation of fibrotic areas using the Globe pulsed field system for symptomatic paroxysmal or persistent atrial fibrillation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study uses the Globe Pulsed Field System to perform pulmonary vein isolation (PVI) combined with box isolation of fibrotic areas (BIFA) in patients with recurrent symptomatic paroxysmal or persistent atrial fibrillation who have failed at least one Class I or III antiarrhythmic drug. The protocol focuses on device-related safety and on effectiveness measured as freedom from atrial arrhythmia at 12 months after the procedure. Key exclusions include long‑standing persistent AF (>12 months), prior left atrial ablation, implanted cardiac devices, significant LV dysfunction, recent thromboembolic or coronary events, and very large left atria. Procedures and follow-up are conducted at the coordinating site in Kaiserslautern, Germany, with systematic clinical and rhythm monitoring over the 12‑month follow-up period.

Why it matters

Who can join: the full rules

Key inclusion criteria:

* A diagnosis of recurrent symptomatic paroxysmal or persistent AF
* Failure or intolerance of at least one antiarrhythmic drug (AAD) Class I or III

Key exclusion criteria:

* Long-standing persistent AF (sustained \>12 months)
* Atrial fibrillation secondary to a reversible cause or of non-cardiac origin
* History of thromboembolic events within the past six months
* Myocardial infarction (MI)/percutaneous coronary intervention (PCI) within the last three months
* Any cardiac surgery within the previous six months
* Prior left atrial ablation or surgical procedure
* Presence of an implanted cardiac device
* Body mass index (BMI) \>40 kg/m\^2
* Left ventricular ejection fraction (LVEF) \<35%
* Anterior-posterior left atrial (LA) diameter \>55mm

Where it's running

• Westpfalz-Klinikum GmbH Kaiserslautern
  Kaiserslautern, Germany Recruiting

Study contacts

• Study coordinator: Clinical Affairs
• Email: Clinical.Affairs@kardium.com
• Phone: +1 (604) 248 8891

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.