Clinical trial NCT05462145: Safety and Effectiveness of the Globe® Pulsed Field System for Treating Patients With Symptomatic Paroxysmal or Persistent Atrial Fibrillation
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Paroxysmal Atrial Fibrillation
Persistent Atrial Fibrillation
Keywords: Pulsed Field Ablation
Irreversible Electroporation
Lead sponsor: Kardium Inc.
Sponsor class: INDUSTRY
First posted: 2022-07-18
Enrollment: 549
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: Key inclusion criteria:

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

Key exclusion criteria:

* 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

Primary outcomes:
measure: Effectiveness endpoint
timeFrame: 12 months
measure: Safety endpoint
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Heersink School of Medicine
state: Alabama
city: Birmingham
country: United States
facility: Grandview Medical Center
state: Alabama
city: Jonesboro
country: United States
facility: St. Bernards Medical Center
state: Arkansas
city: San Francisco
country: United States
facility: Sutter Health - California Pacific Medical Center
state: California
city: Jacksonville
country: United States
facility: St. Vincent's Medical Center
state: Florida
city: Miami
country: United States
facility: Mercy Hospital
state: Florida
city: Baltimore
country: United States
facility: Johns Hopkins
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Royal Oak
country: United States
facility: Beaumont Hospital
state: Michigan
city: New York
country: United States
facility: Mt. Sinai Hospital, Guggenheim Pavilion
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Doylestown
country: United States
facility: Doylestown Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Vancouver
country: Canada
facility: St.Paul's Hospital
state: British Columbia
city: Montréal
country: Canada
facility: McGill University Health Centre
state: Quebec
city: Praha
country: Czechia
facility: Nemocnice Na Homolce
city: Bad Oeynhausen
country: Germany
facility: Heart and Diabetes Center NRW
city: Berlin
country: Germany
facility: Charité Campus Virchow Clinic
city: Kaiserslautern
country: Germany
facility: Westpfalz-Klinikum GmbH Kaiserslautern
Study officials:
References: