Pulmonary vein isolation plus box isolation of fibrotic areas using the Globe pulsed field system for symptomatic paroxysmal or persistent atrial fibrillation
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
This trial will test whether using the Globe pulsed field system to perform pulmonary vein isolation plus box isolation of fibrotic areas helps people with symptomatic paroxysmal or persistent atrial fibrillation stay free of arrhythmia over 12 months.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 115 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Kardium Inc. Industry-sponsored |
| Locations | 1 site (Kaiserslautern) |
| Trial ID | NCT06973031 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults with recurrent symptomatic paroxysmal or persistent AF who have failed or cannot tolerate at least one Class I or III antiarrhythmic drug, who have acceptable LV function, BMI, and left atrial size, and who have not had prior left atrial ablation or an implanted cardiac device.
Not a fit: Patients with long‑standing persistent AF (>12 months), prior left atrial ablation or surgery, implanted cardiac devices, LVEF <35%, BMI >40 kg/m2, very large left atria, recent thromboembolic or recent MI/PCI are unlikely to receive benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could offer a non‑thermal ablation option that reduces AF recurrence while limiting collateral tissue injury compared with some conventional energy sources.
How similar studies have performed: Pulsed field ablation has shown promising safety and efficacy in other pulmonary vein isolation studies, but combining PVI with targeted box isolation of fibrotic areas is a newer approach with limited prior data.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Kaiserslautern
- Westpfalz-Klinikum GmbH Kaiserslautern — Kaiserslautern, Germany (Recruiting)
Study contacts
- Study coordinator: Clinical Affairs
- Email: Clinical.Affairs@kardium.com
- Phone: +1 (604) 248 8891
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.