NCT06973031Recruiting
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
Source: ClinicalTrials.gov · Last updated 16 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 115 (estimated)
- First submitted
- 7 May 2025
- Start date
- 10 Jun 2025
- Primary completion date
- Jun 2028
- Lead sponsor
- Kardium Inc.
- Diseases
- Atrial fibrillation
- NCT number
- NCT06973031
What you commit to
- Study type: Interventional
- Planned participants: 115
- From 10 Jun 2025 to the primary completion date, Jun 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any cardiac surgery within the previous six months
- Prior left atrial ablation or surgical procedure
Other illness
- 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
Lab values
- Left ventricular ejection fraction (LVEF) \<35%
Other
- Long-standing persistent AF (sustained \>12 months)
- Body mass index (BMI) \>40 kg/m\^2
- Anterior-posterior left atrial (LA) diameter \>55mm
Who the study is looking for
- A diagnosis of recurrent symptomatic paroxysmal or persistent AF
- Failure or intolerance of at least one antiarrhythmic drug (AAD) Class I or III
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Westpfalz-Klinikum GmbH Kaiserslautern Coordinator of this site? Confirm its status | Kaiserslautern | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.