Safety and Performance of a Pulsed Field Device for Global Mapping and Ablation of the Left Atrium for the Treatment of Atrial Fibrillation

NCT05164107 | Recruiting

• 1 other identifier: DOC-140832
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to provide clinical data pertaining to the safety and performance of the Globe Mapping and Pulsed Field Ablation System for treating subjects with atrial fibrillation (AF).

Conditions

Atrial Fibrillation

Keywords

Globe Mapping and Ablation System; Atrial Fibrillation; Pulsed Field Ablation

Outcome Measures

Primary Outcomes (1)

• Rate of subjects presenting with primary safety events which are device- or procedure-related

  up to 3-month visit

Study Arms (1)

Globe Mapping and Pulsed Field Ablation System

EXPERIMENTAL

Device: Globe Mapping and Pulsed Field Ablation System (Globe PF System)

Interventions

Globe Mapping and Pulsed Field Ablation System (Globe PF System) DEVICE

During the procedure, the Globe Catheter will be delivered via standard femoral vein access and transseptal puncture. Anatomical and electrophysiological mapping of the left atrium (LA) will be followed by pulsed field ablation (PFA) to achieve pulmonary vein isolation (PVI). Additional PFA or radiofrequency (RF) ablation lesions may be created as deemed appropriate by the Investigator. Intracardiac electrogram mapping with the Globe PF System will be used to confirm PVI.

Globe Mapping and Pulsed Field Ablation System

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects planned for an AF catheter ablation procedure, with a documented history of AF.
• Diagnosis must be confirmed within 12 months before enrollment.
• (Repeat ablations) Patient had 1 previous PVI procedure with cryoablation, radiofrequency ablation or pulsed field ablation
• Subjects between 18 and 75 years of age, inclusive

You may not qualify if:

• Patients who have contraindications to open heart surgery
• Patients from an Intensive Care Unit
• Patients with active systemic infection (sepsis)
• Patients who have had previous ablation in the left or right atrium
• Patients who are post-heart transplant or who are awaiting cardiac transplantation or other cardiac surgery
• Patients with cardiac implants that may interfere with device delivery or positioning (e.g. atrial septal defect closure device, left atrial appendage occluder)
• Patients with mitral valve prolapse or other heart valve abnormalities excepting mild to moderate mitral regurgitation
• Patients with New York Heart Association Class III or IV heart failure
• History of a documented thromboembolic event, including stroke or transient ischemic attack (TIA)
• Bleeding disorder history
• Patients with a known sensitivity to anesthesia or neuromuscular block agent
• Currently undergoing long-term treatment with steroids, not including intermittent use of inhaled steroids for respiratory disease
• Myocardial infarction within the last three months
• Atrioventricular (AV) block II° or III°
• Left ventricular ejection fraction (LVEF) of less than 35%

Sponsors & Collaborators

• Kardium Inc.: lead

Study Sites (1)

Motol and Homolka University Hospital

Prague, 150 00, Czechia

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• Motol and Homolka University Hospital

  V Úvalu 84/1, 150 00 Prague 5, Czech Republic

  PRINCIPAL INVESTIGATOR

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: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2021
• First Posted: December 20, 2021
• Study Start: December 8, 2021
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: January 30, 2026

Record last verified: 2026-01

Locations

CZ (1)