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

PULSE-EU - A Prospective, Non-Randomized Clinical Pilot Study to Assess Safety and Performance of a Pulsed Field Device for Global Mapping and Ablation of the Left Atrium for the Treatment of Atrial Fibrillation

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05164107

Acronym

PULSE-EU

Enrollment

175

Registered

2021-12-20

Start date

2021-12-08

Completion date

2027-05-01

Last updated

2026-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

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

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).

Interventions

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

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

Key Inclusion Criteria: 1. Subjects planned for an AF catheter ablation procedure, with a documented history of AF. 1. Diagnosis must be confirmed within 12 months before enrollment. 2. (Repeat ablations) Patient had 1 previous PVI procedure with cryoablation, radiofrequency ablation or pulsed field ablation 2. Subjects between 18 and 75 years of age, inclusive Key

Exclusion criteria

1. Patients who have contraindications to open heart surgery 2. Patients from an Intensive Care Unit 3. Patients with active systemic infection (sepsis) 4. Patients who have had previous ablation in the left or right atrium 5. Patients who are post-heart transplant or who are awaiting cardiac transplantation or other cardiac surgery 6. Patients with cardiac implants that may interfere with device delivery or positioning (e.g. atrial septal defect closure device, left atrial appendage occluder) 7. Patients with mitral valve prolapse or other heart valve abnormalities excepting mild to moderate mitral regurgitation 8. Patients with New York Heart Association Class III or IV heart failure 9. History of a documented thromboembolic event, including stroke or transient ischemic attack (TIA) 10. Bleeding disorder history 11. Patients with a known sensitivity to anesthesia or neuromuscular block agent 12. Currently undergoing long-term treatment with steroids, not including intermittent use of inhaled steroids for respiratory disease 13. Myocardial infarction within the last three months 14. Atrioventricular (AV) block II° or III° 15. Left ventricular ejection fraction (LVEF) of less than 35% 16. Unstable angina

Design outcomes

Primary

Measure	Time frame
Rate of subjects presenting with primary safety events which are device- or procedure-related	up to 3-month visit

Countries

Czechia

Contacts

CONTACTClinical Affairs

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

PRINCIPAL_INVESTIGATORMotol and Homolka University Hospital

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026