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

Not Applicable

Recruiting

• Conditions: Atrial Fibrillation
• Interventions: Device: Globe Mapping and Pulsed Field Ablation System (Globe PF System)

• Registration Number: NCT05164107
• Lead Sponsor: Kardium Inc.

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-06
• Study Start: 2021-12-08
• Study First Submitted QC: 2021-12-17
• Study First Posted: 2021-12-20
• Status Verified: 2024-02
• Last Update Submitted: 2024-04-23
• Last Update Posted: 2024-04-25
• Primary Completion: 2026-03
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 135

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Globe Mapping and Pulsed Field Ablation System	Globe Mapping and Pulsed Field Ablation System (Globe PF System)	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Nemocnice Na Homolce; 🇨🇿 Praha, Czechia