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

Atrial Fibrillation Clinical Trial

— PULSE-EU  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05164107
• Other study ID #: DOC-140832
• Status: Recruiting
• Phase: N/A
• Start date: December 8, 2021
• Est. completion date: March 2026

Study information

• Verified date: February 2024
• Source: Kardium Inc.
• Contact: Clinical Affairs
• Phone: +1 (604) 248 8891
• Email: Clinical.Affairs[@]kardium.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 135
• Est. completion date: March 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Subjects planned for an AF catheter ablation procedure, with a documented history of AF. Diagnosis must be confirmed within 12 months before enrollment.

2. Subjects between 18 and 75 years of age, inclusive

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• Globe 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.

Locations

Country	Name	City	State
Czechia	Nemocnice Na Homolce	Praha

Sponsors (1)

Lead Sponsor	Collaborator
Kardium Inc.

Country where clinical trial is conducted

Czechia, 

Outcome

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