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

NCT07714876 | Not Yet Recruiting FDA Device

• 1 other identifier: DOC-323676
• Study Type: interventional
• Target: 250
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will evaluate the long-term safety and effectiveness of the Globe® Pulsed Field System for treating patients with symptomatic paroxysmal atrial fibrillation.

Conditions

Paroxysmal Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• 12-month Treatment Success Rate

  The rate of 12-month treatment success following ablation procedure using the Globe Pulsed Field System. Treatment success is defined as freedom from treatment failure, where treatment failure includes: * Documented recurrence of atrial fibrillation, atrial flutter, atrial tachycardia (AF/AFL/AT) as evidenced by episodes ≥ 30 seconds on Holter monitoring or equivalent during the effectiveness evaluation period, or by an episode documented on the entire recording of the 12-lead ECG (≥ 10 seconds) at the 12-month evaluation/visit. * Acute procedural failure * Direct current (DC) cardioversion for AF/AFL/AT during the effectiveness evaluation period * Redo ablation failure * Antiarrhythmic drugs (AADs) failure * Surgical treatment for AF/AFL/AT after the index procedure

  12 months

• Primary Safety Event Rate

  Rate of subjects presenting with one or more primary safety events up to and including 7 days after the index ablation procedure. Primary safety events comprise the following device- or procedure-related serious adverse events: * Death * Cardiac tamponade/perforation * Heart block * Major vascular access complication * Major bleeding * Myocardial infarction (MI) * Pericarditis requiring intervention * Pulmonary edema * Stroke/cerebrovascular accident (CVA) * Thromboembolism * Transient ischemic attack (TIA) * Vagal nerve injury resulting in gastroparesis * Atrio-esophageal fistula * Diaphragmatic paralysis/phrenic nerve injury * Severe pulmonary vein (PV) stenosis

  7 days

Study Arms (1)

Globe Pulsed Field System

EXPERIMENTAL

Device: Globe Pulsed Field System

Interventions

Globe Pulsed Field System DEVICE

Ablation and atrial mapping with the Globe Pulsed Field System

Globe Pulsed Field System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Persistent or long-standing persistent atrial fibrillation (continuous atrial fibrillation that is 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 any pulmonary vein stents
• Body mass index (BMI) \>40 kg/m\^2
• Left ventricular ejection fraction (LVEF) \<35%
• Anterior-posterior left atrial (LA) diameter \>55mm

Sponsors & Collaborators

• Kardium Inc.: lead

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Clinical Affairs

CONTACT

+1 (604) 248 8891; Clinical.Affairs@kardium.com

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 10, 2026
• First Posted: July 20, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2031
• Last Updated: July 20, 2026

Record last verified: 2026-07