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
Recruiting · NCT06973031 · Interventional (participants receive a specific treatment) · Lead sponsor: Kardium Inc.
View the official record on ClinicalTrials.gov →Interventions studied
Globe Pulsed Field System
What this trial is about
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.
Who can take part
Age range
18 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed.
- Westpfalz-Klinikum GmbH Kaiserslautern - Kaiserslautern, Germany