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

Not Applicable

Active, not recruiting

• Conditions: Persistent Atrial Fibrillation; Paroxysmal Atrial Fibrillation
• Interventions: Device: Globe Pulsed Field System

• 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: 2025-04
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-08
• Primary Completion: 2026-09
• Study Completion: 2026-09

Recruitment & Eligibility

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

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Globe Pulsed Field System	Globe Pulsed Field System	-

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 (19)

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

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

St.Paul's Hospital; 🇨🇦 Vancouver, British Columbia, Canada

McGill University Health Centre; 🇨🇦 Montréal, Quebec, Canada

Nemocnice Na Homolce; 🇨🇿 Praha, Czechia

Heart and Diabetes Center NRW; 🇩🇪 Bad Oeynhausen, Germany

Charité Campus Virchow Clinic; 🇩🇪 Berlin, Germany

Westpfalz-Klinikum GmbH Kaiserslautern; 🇩🇪 Kaiserslautern, Germany