Tests a pulsed field ablation device for atrial fibrillation heart rhythm
Tests a pulsed field heart device to treat irregular heartbeat in adults with atrial fibrillation.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Kaiserslautern, GermanySee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT06973031, who can take part
Where in Germany
- Westpfalz-Klinikum GmbH KaiserslauternKaiserslautern, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Kardium Inc.
- Trial code
- NCT06973031
- Record updated
- 16 June 2025
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: A diagnosis of recurrent symptomatic paroxysmal or persistent AF; Failure or intolerance of at least one antiarrhythmic drug (AAD) Class I or III.
Exclusion: Any cardiac surgery within the previous six months; Prior left atrial ablation or surgical procedure; 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; Presence of an implanted cardiac device; Left ventricular ejection fraction (LVEF) <35%; Long-standing persistent AF (sustained >12 months); Body mass index (BMI) >40 kg/m\^2; Anterior-posterior left atrial (LA) diameter >55mm.