Safety and Effectiveness of the Globe® Pulsed Field System for Treating Patients With Symptomatic Paroxysmal or Persistent Atrial Fibrillation

NCT05462145 — Not applicable, Active not recruiting, 549 participants, Kardium Inc.
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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

RegistryNCT05462145, acronym PULSAR
StatusActive not recruiting
PhaseNot applicable
Study typeInterventional; na, single group, masking: none, treatment
Enrollment549 (Estimated)
SponsorKardium Inc. (Industry)
ConditionsParoxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
InterventionsGlobe Pulsed Field System (Device)
Datesstart 2023-03-09, primary completion 2029-03-01 (estimated), completion 2029-03-01 (estimated), first posted 2022-07-18, last updated 2026-10-06
Locations17 sites in United States, Canada, Czechia, Germany

Related Papers Related Patents Related Grants Related Experts
All trials for Paroxysmal Atrial Fibrillation All trials for Persistent Atrial Fibrillation All trials of Globe Pulsed Field System

-Summary

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).

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+Arms and interventions

ArmTypeInterventionsDescription
Globe Pulsed Field SystemExperimentalDevice: Globe Pulsed Field System
  • Globe Pulsed Field System (Device): Ablation and atrial mapping with the Globe Pulsed Field System

+Outcome measures

Primary outcomes

  • Effectiveness endpoint [12 months]: Number of subjects with freedom from documented atrial fibrillation, atrial flutter, and atrial tachycardia (AF/AFL/AT) 12 months post-procedure.
  • Safety endpoint [7 days]: Rate of subjects presenting with one or more of the specified primary safety events within 7 days of the index ablation procedure.

+Eligibility

Sex: All, ages: 18 Years to 80 Years

Key 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 or AAD naïve subjects

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
* Right atrial minor-axis (transverse) diameter <32mm for adjunctive cavotricuspid isthmus (CTI) ablation only

+Locations (17)

FacilityCityCountryStatus
Grandview Medical CenterBirmingham, AlabamaUnited States
St. Bernards Medical CenterJonesboro, ArkansasUnited States
Sutter Health - California Pacific Medical CenterSan Francisco, CaliforniaUnited States
St. Vincent's Medical CenterJacksonville, FloridaUnited States
Mercy HospitalMiami, FloridaUnited States
Johns HopkinsBaltimore, MarylandUnited States
Beaumont HospitalRoyal Oak, MichiganUnited States
Mt. Sinai Hospital, Guggenheim PavilionNew York, New YorkUnited States
Cleveland ClinicCleveland, OhioUnited States
Hospital of the University of PennsylvaniaPhiladelphia, PennsylvaniaUnited States
Texas Cardiac Arrhythmia Research FoundationAustin, TexasUnited States
St.Paul's HospitalVancouver, British ColumbiaCanada
McGill University Health CentreMontreal, QuebecCanada
Motol and Homolka University HospitalPragueCzechia
Heart and Diabetes Center NRWBad OeynhausenGermany
Charité Campus Virchow ClinicBerlinGermany
Westpfalz-Klinikum GmbH KaiserslauternKaiserslauternGermany

+Publications

  • Reddy VY, Kottkamp H, Calkins H, Nair DG, Sommer P, Hussein AA, Schumacher B, Dukkipati S, Neuzil P, Oza S, Woods C, Deyell MW, Osorio J, Verma A; PULSAR Investigators. Pulsed-Field Ablation to Enhance the Durability of Pulmonary Vein Isolation and Treat Paroxysmal Atrial Fibrillation. J Am Coll Cardiol. 2026 Apr 14;87(14):1747-1761. doi: 10.1016/j.jacc.2025.10.084. Epub 2026 Jan 21. PMID 41563170