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NCT07714876Not yet recruiting

Evaluation of the Safety and Effectiveness of the Globe® Pulsed Field System for Treating Patients With Symptomatic Paroxysmal 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 Atrial Fibrillation - Post Approval Study

Source: ClinicalTrials.gov · Last updated 20 Jul 2026

Brief summary (registry, in English)

This study will evaluate the long-term safety and effectiveness of the Globe® Pulsed Field System for treating patients with symptomatic paroxysmal atrial fibrillation.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
250 (estimated)
First submitted
10 Jul 2026
Start date
Dec 2026
Primary completion date
Dec 2029
Lead sponsor
Kardium Inc.
NCT number
NCT07714876

What you commit to

  • Study type: Interventional
  • Planned participants: 250
  • From Dec 2026 to the primary completion date, Dec 2029
  • No sites listed in no 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

Lab values

  • Left ventricular ejection fraction (LVEF) \<35%

Other

  • Persistent or long-standing persistent atrial fibrillation (continuous atrial fibrillation that is sustained \>12 months)
  • Presence of any pulmonary vein stents
  • 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 atrial fibrillation
  • Failure or intolerance of at least one antiarrhythmic drug (AAD) Class I or III

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.