NCT05462145Active, not recruiting
Safety and Effectiveness of the Globe® Pulsed Field System for Treating Patients With Symptomatic Paroxysmal or Persistent Atrial Fibrillation
A Prospective, Multicenter Clinical Study to Evaluate the Safety and Effectiveness of the Globe® Pulsed Field System for Treating Patients With Symptomatic Paroxysmal or Persistent Atrial Fibrillation
Source: ClinicalTrials.gov · Last updated 6 Oct 2026
Brief summary (registry, in English)
This study will evaluate the safety and effectiveness of the Globe® Pulsed Field System for treating patients with symptomatic paroxysmal or persistent atrial fibrillation (AF).
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 549 (estimated)
- First submitted
- 13 Jul 2022
- Start date
- Mar 2023
- Primary completion date
- Mar 2029
- Lead sponsor
- Kardium Inc.
- Diseases
- Atrial fibrillation
- NCT number
- NCT05462145
What you commit to
- Study type: Interventional
- Planned participants: 549
- From Mar 2023 to the primary completion date, Mar 2029
- 17 sites in 4 countries
- 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
- Right atrial minor-axis (transverse) diameter \<32mm for adjunctive cavotricuspid isthmus (CTI) ablation only
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 or AAD naïve subjects
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (17)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| McGill University Health Centre Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| St. Paul's Hospital Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
| Motol and Homolka University Hospital Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| Heart and Diabetes Center NRW Coordinator of this site? Confirm its status | Bad Oeynhausen | Germany | Unknown status |
| Charité Campus Virchow Clinic Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| Westpfalz-Klinikum GmbH Kaiserslautern Coordinator of this site? Confirm its status | Kaiserslautern | Germany | Unknown status |
| Texas Cardiac Arrhythmia Research Foundation Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Johns Hopkins Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Grandview Medical Center Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| St. Vincent's Medical Center Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| St. Bernards Medical Center Coordinator of this site? Confirm its status | Jonesboro | United States | Unknown status |
| Mercy Hospital Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Mt. Sinai Hospital, Guggenheim Pavilion Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Hospital of the University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Beaumont Hospital Coordinator of this site? Confirm its status | Royal Oak | United States | Unknown status |
| Sutter Health - California Pacific Medical Center Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
Related publications
- Pulsed-Field Ablation to Enhance the Durability of Pulmonary Vein Isolation and Treat Paroxysmal Atrial Fibrillation.J Am Coll Cardiol · 2026 · PMID 41563170
This page is information, not medical advice. Discuss any trial with your doctor.