Recruiting NCT05164107
Safety and Performance of a Pulsed Field Device for Global Mapping and Ablation of the Left Atrium for the Treatment of Atrial Fibrillation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Globe Mapping and Pulsed Field Ablation System (Globe PF System).
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Czechia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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).
Interventions
- 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.
Primary outcome measures
- Rate of subjects presenting with primary safety events which are device- or procedure-related [Time frame: up to 3-month visit]
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.
- (Repeat ablations) Patient had 1 previous PVI procedure with cryoablation, radiofrequency ablation or pulsed field ablation
- 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 who have had previous ablation in the left or right 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°
- Left ventricular ejection fraction (LVEF) of less than 35%
- Unstable angina
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
Czechia · 1 center
- Motol and Homolka University Hospital — Prague
Identifiers
NCT: NCT05164107 · DOC-140832