Safety and Performance of a Pulsed Field Device for Global Mapping and Ablation of the Left Atrium for the Treatment of Atrial Fibrillation
Recruiting · NCT05164107 · Interventional (participants receive a specific treatment) · Lead sponsor: Kardium Inc.
View the official record on ClinicalTrials.gov →Interventions studied
Globe Mapping and Pulsed Field Ablation System (Globe PF System)
What this trial is about
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).
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
- Key
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
Where it is running
1 location listed.
- Motol and Homolka University Hospital - Prague, Czechia