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

• Sponsor: Kardium Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05164107
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 8.8
• Patients Per Site Per Month: 4.6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Device: Globe Mapping and Ablation System (Globe System)	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• 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
• Actual Study Start Date: Dec 8, 2021
• Anticipated Primary Completion Date: Sep 1, 2022
• Anticipated Study Completion Date: Sep 1, 2022

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Globe Mapping and Ablation System

Device: Globe Mapping and Ablation System (Globe 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 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 System will be used to confirm PVI.

Outcome Measures

Primary Outcome Measures

1. Rate of subjects presenting with primary safety events which are device- or procedure-related [up to 3-month visit]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 requiring concomitant right atrial ablation (as determined before the procedure)

5. Patients who have had previous ablation in the left atrium

6. Patients who are post-heart transplant or who are awaiting cardiac transplantation or other cardiac surgery

7. Patients with cardiac implants that may interfere with device delivery or positioning (e.g. atrial septal defect closure device, left atrial appendage occluder)

8. Patients with mitral valve prolapse or other heart valve abnormalities excepting mild to moderate mitral regurgitation

9. Patients with New York Heart Association Class III or IV heart failure

10. History of a documented thromboembolic event, including stroke or transient ischemic attack (TIA)

11. Bleeding disorder history

12. Patients with a known sensitivity to anesthesia or neuromuscular block agent

13. Currently undergoing long-term treatment with steroids, not including intermittent use of inhaled steroids for respiratory disease

14. Myocardial infarction within the last three months

15. Atrioventricular (AV) block II° or III°

16. Atrial flutter

17. Left ventricular ejection fraction (LVEF) of less than 35%

18. Unstable angina

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nemocnice Na Homolce	Praha		Czechia	150 30

Sponsors and Collaborators

• Kardium Inc.

Investigators

• Principal Investigator: Nemocnice Na Homolce, Roentgenova 37/2, 150 30 Praha 5 - Motol, Czech Republic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kardium Inc.
• ClinicalTrials.gov Identifier: NCT05164107
• Other Study ID Numbers: DOC-140832
• First Posted: Dec 20, 2021
• Last Update Posted: Jul 14, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Kardium Inc.: Globe Mapping and Ablation System; Atrial Fibrillation; Pulsed Field Ablation
• Additional relevant MeSH terms: Atrial Fibrillation

Study Results

No Results Posted as of Jul 14, 2022