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

Not Applicable

Recruiting

• Conditions: Persistent Atrial Fibrillation; Paroxysmal Atrial Fibrillation

• Registration Number: NCT05462145
• Lead Sponsor: Kardium Inc.

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-13
• Study First Submitted QC: 2022-07-15
• Study First Posted: 2022-07-18
• Study Start: 2023-03-09
• Status Verified: 2025-06
• Last Update Submitted: 2025-07-03
• Last Update Posted: 2025-07-04
• Primary Completion: 2026-09
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 549

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (20)

Texas Cardiac Arrhythmia Research Foundation; 🇺🇸 Austin, Texas, United States

University of Alabama Heersink School of Medicine; 🇺🇸 Birmingham, Alabama, United States

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

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Beaumont Hospital; 🇺🇸 Royal Oak, Michigan, United States

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