NCT05462145

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).

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
549

participants targeted

Target at P75+ for not_applicable

Timeline
3mo left

Started Mar 2023

Longer than P75 for not_applicable

Geographic Reach
4 countries

18 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Mar 2023Sep 2026

First Submitted

Initial submission to the registry

July 13, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 18, 2022

Completed
8 months until next milestone

Study Start

First participant enrolled

March 9, 2023

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

3.5 years

First QC Date

July 13, 2022

Last Update Submit

January 28, 2026

Conditions

Persistent Atrial FibrillationParoxysmal Atrial Fibrillation

Keywords

Pulsed Field AblationIrreversible Electroporation

Outcome Measures

Primary Outcomes (2)

  • Effectiveness endpoint

    Number of subjects with freedom from documented atrial fibrillation, atrial flutter, and atrial tachycardia (AF/AFL/AT) 12 months post-procedure.

    12 months

  • Safety endpoint

    Rate of subjects presenting with one or more of the specified primary safety events within 7 days of the index ablation procedure.

    7 days

Study Arms (1)

Globe Pulsed Field System

EXPERIMENTAL
Device: Globe Pulsed Field System

Interventions

Globe Pulsed Field SystemDEVICE

Ablation and atrial mapping with the Globe Pulsed Field System

Globe Pulsed Field System

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A diagnosis of recurrent symptomatic paroxysmal or persistent AF
  • Failure or intolerance of at least one antiarrhythmic drug (AAD) Class I or III

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Grandview Medical Center

Birmingham, Alabama, 35243, United States

Location

St. Bernards Medical Center

Jonesboro, Arkansas, 72401, United States

Location

Sutter Health - California Pacific Medical Center

San Francisco, California, 94109, United States

Location

St. Vincent's Medical Center

Jacksonville, Florida, 32204, United States

Location

Mercy Hospital

Miami, Florida, 33133, United States

Location

Johns Hopkins

Baltimore, Maryland, 21287, United States

Location

Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Mt. Sinai Hospital, Guggenheim Pavilion

New York, New York, 10029, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Doylestown Hospital

Doylestown, Pennsylvania, 18901, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, 78705, United States

Location

St.Paul's Hospital

Vancouver, British Columbia, V6E 1M7, Canada

Location

McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

Location

Motol and Homolka University Hospital

Prague, Czechia

Location

Heart and Diabetes Center NRW

Bad Oeynhausen, Germany

Location

Charité Campus Virchow Clinic

Berlin, Germany

Location

Westpfalz-Klinikum GmbH Kaiserslautern

Kaiserslautern, 67655, Germany

Location

Related Publications (1)

  • 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.

    PMID: 41563170BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2022

First Posted

July 18, 2022

Study Start

March 9, 2023

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

January 30, 2026

Record last verified: 2026-01

Locations

DE(3)CZ(1)US(12)CA(2)