Tests a pulsed field heart device for atrial fibrillation treatment
Tests a pulsed field mapping and ablation device in adults with atrial fibrillation.
Plain-language title generated from the registry record
Registry title: Safety and Performance of a Pulsed Field Device for Global Mapping and Ablation of the Left Atrium for the Treatment of Atrial Fibrillation
Key facts
- Where
- Prague, CzechiaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT05164107, who can take part
Where in Czechia
- Motol and Homolka University HospitalPrague, CzechiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Kardium Inc.
- Trial code
- NCT05164107
- Record updated
- 30 January 2026
- Original description
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).Read full original descriptionShow less
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).
Inclusion: 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: 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; 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; Left ventricular ejection fraction (LVEF) of less than 35%; Patients from an Intensive Care Unit; Patients with a known sensitivity to anesthesia or neuromuscular block agent; Atrioventricular (AV) block II° or III°.