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
NCT ID: NCT06973031
Last Updated: 2025-06-16
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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RECRUITING
NA
115 participants
INTERVENTIONAL
2025-06-10
2028-06-30
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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Westpfalz-Klinikum GmbH Kaiserslautern
Kaiserslautern, , Germany
Countries
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Central Contacts
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Other Identifiers
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DOC-285345
Identifier Type: -
Identifier Source: org_study_id
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