RECRUITING

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

Description

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).

Conditions

Paroxysmal Atrial FibrillationPersistent Atrial Fibrillation
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Related Conditions:

Paroxysmal Atrial FibrillationPersistent Atrial Fibrillation

Study Overview

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Study Details

Study overview

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).

A Prospective, Multicenter Clinical Study to Evaluate the Safety and Effectiveness of the Globe® Pulsed Field System for Treating Patients With Symptomatic Paroxysmal or Persistent Atrial Fibrillation

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

Condition
Paroxysmal Atrial Fibrillation
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama Heersink School of Medicine, Birmingham, Alabama, United States, 35233

Birmingham

Grandview Medical Center, Birmingham, Alabama, United States, 35243

Jonesboro

St. Bernards Medical Center, Jonesboro, Arkansas, United States, 72401

San Francisco

Sutter Health - California Pacific Medical Center, San Francisco, California, United States, 94109

Jacksonville

St. Vincent's Medical Center, Jacksonville, Florida, United States, 32204

Miami

Mercy Hospital, Miami, Florida, United States, 33133

Baltimore

Johns Hopkins, Baltimore, Maryland, United States, 21287

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

Royal Oak

Beaumont Hospital, Royal Oak, Michigan, United States, 48073

New York

Mt. Sinai Hospital, Guggenheim Pavilion, New York, New York, United States, 10029

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

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

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Kardium Inc.,

Study Record Dates

2026-09