Back to results

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)

Primary Purpose

Atrial Fibrillation

Status

Recruiting

Phase

Not Applicable

Locations

Czechia

Study Type

Interventional

Intervention

Globe Mapping and Ablation System (Globe System)

About this trial

This is an interventional other trial for Atrial Fibrillation focused on measuring Globe Mapping and Ablation System, Atrial Fibrillation, Pulsed Field Ablation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subjects planned for an AF catheter ablation procedure, with a documented history of AF. Diagnosis must be confirmed within 12 months before enrollment.
Subjects between 18 and 75 years of age, inclusive

Exclusion Criteria:

Patients who have contraindications to open heart surgery
Patients from an Intensive Care Unit
Patients with active systemic infection (sepsis)
Patients requiring concomitant right atrial ablation (as determined before the procedure)
Patients who have had previous ablation in the left 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°
Atrial flutter
Left ventricular ejection fraction (LVEF) of less than 35%
Unstable angina

Sites / Locations

Nemocnice Na HomolceRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Globe Mapping and Ablation System

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05164107

First Posted

December 6, 2021

Last Updated

February 27, 2023

Sponsor

Kardium Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05164107

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 8, 2021 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Kardium Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation

Keywords

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

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Globe Mapping and Ablation System

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Globe Mapping and Ablation System (Globe System)

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Time Frame

up to 3-month visit

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects planned for an AF catheter ablation procedure, with a documented history of AF. Diagnosis must be confirmed within 12 months before enrollment. Subjects between 18 and 75 years of age, inclusive Exclusion Criteria: Patients who have contraindications to open heart surgery Patients from an Intensive Care Unit Patients with active systemic infection (sepsis) Patients requiring concomitant right atrial ablation (as determined before the procedure) Patients who have had previous ablation in the left 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° Atrial flutter Left ventricular ejection fraction (LVEF) of less than 35% Unstable angina

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Clinical Affairs

Phone

+1 (604) 248 8891

Clinical.Affairs@kardium.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nemocnice Na Homolce

Organizational Affiliation

Roentgenova 37/2, 150 30 Praha 5 - Motol, Czech Republic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Nemocnice Na Homolce

City

Praha

ZIP/Postal Code

150 30

Country

Czechia

Individual Site Status

Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs