NCT05164107Recruiting
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 - 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
Source: ClinicalTrials.gov · Last updated 30 Jan 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 175 (estimated)
- First submitted
- 6 Dec 2021
- Start date
- 8 Dec 2021
- Primary completion date
- May 2027
- Lead sponsor
- Kardium Inc.
- Diseases
- Atrial fibrillation
- NCT number
- NCT05164107
What you commit to
- Study type: Interventional
- Planned participants: 175
- From 8 Dec 2021 to the primary completion date, May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have had previous ablation in the left or right atrium
- Currently undergoing long-term treatment with steroids, not including intermittent use of inhaled steroids for respiratory disease
Other illness
- Patients who have contraindications to open heart surgery
- Patients with active systemic infection (sepsis)
- 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
- Myocardial infarction within the last three months
- Unstable angina
Lab values
- Left ventricular ejection fraction (LVEF) of less than 35%
Other
- Patients from an Intensive Care Unit
- Patients with a known sensitivity to anesthesia or neuromuscular block agent
- Atrioventricular (AV) block II° or III°
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Motol and Homolka University Hospital Coordinator of this site? Confirm its status | Prague | Czechia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.