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)

April 23, 2024 updated by: Kardium Inc.

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

135

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Czechia
      • Praha, Czechia, 150 30
        • Recruiting
        • Nemocnice Na Homolce

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Globe Mapping and Pulsed Field Ablation System
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kardium Inc.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 8, 2021

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

December 6, 2021

First Submitted That Met QC Criteria

December 17, 2021

First Posted (Actual)

December 20, 2021

Study Record Updates

Last Update Posted (Estimated)

April 25, 2024

Last Update Submitted That Met QC Criteria

April 23, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DOC-140832

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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