Safety and Effectiveness of the Globe® Pulsed Field System for Treating Patients With Symptomatic Paroxysmal or Persistent Atrial Fibrillation
NCT ID: NCT05462145
Last Updated: 2026-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
549 participants
INTERVENTIONAL
2023-03-09
2026-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Globe Pulsed Field System
Globe Pulsed Field System
Ablation and atrial mapping with the Globe Pulsed Field System
Interventions
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Globe Pulsed Field System
Ablation and atrial mapping with the Globe Pulsed Field System
Eligibility Criteria
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Inclusion Criteria
* Failure or intolerance of at least one antiarrhythmic drug (AAD) Class I or III
Exclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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Kardium Inc.
INDUSTRY
Responsible Party
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Locations
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Grandview Medical Center
Birmingham, Alabama, United States
St. Bernards Medical Center
Jonesboro, Arkansas, United States
Sutter Health - California Pacific Medical Center
San Francisco, California, United States
St. Vincent's Medical Center
Jacksonville, Florida, United States
Mercy Hospital
Miami, Florida, United States
Johns Hopkins
Baltimore, Maryland, United States
Beaumont Hospital
Royal Oak, Michigan, United States
Mt. Sinai Hospital, Guggenheim Pavilion
New York, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
Doylestown Hospital
Doylestown, Pennsylvania, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, United States
St.Paul's Hospital
Vancouver, British Columbia, Canada
McGill University Health Centre
Montreal, Quebec, Canada
Motol and Homolka University Hospital
Prague, , Czechia
Heart and Diabetes Center NRW
Bad Oeynhausen, , Germany
Charité Campus Virchow Clinic
Berlin, , Germany
Westpfalz-Klinikum GmbH Kaiserslautern
Kaiserslautern, , Germany
Countries
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References
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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 Jan 14:S0735-1097(25)10256-8. doi: 10.1016/j.jacc.2025.10.084. Online ahead of print.
Other Identifiers
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DOC-189367
Identifier Type: -
Identifier Source: org_study_id
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