Actively Recruiting
Safety and Effectiveness of the CardioWave Pulsed Field Ablation System With QuickShot Nav Large-Area Focal Catheter for Persistent Atrial Fibrillation
Led by CardioFocus · Updated on 2025-12-15
200
Participants Needed
3
Research Sites
43 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of the investigational QuickShot Nav configuration of the CardioWave System using a pulsed field ablation device with a large-area focal catheter for treating persistent atrial fibrillation (PerAF). This prospective, single-arm, multi-center clinical study plans to enroll up to 200 participants across up to 4 centers in Europe. The study focuses on participants with symptomatic persistent or paroxysmal atrial fibrillation who have not responded well to at least one antiarrhythmic drug. Participants will receive catheter ablation treatment using the pulsed field ablation system with the large-area focal catheter. The study includes different phases: Phase A and B participants complete the study after hospital discharge post-remapping procedure, while Phase C participants will be followed for 12 months after treatment. All eligible patients who consent will undergo the ablation procedure according to study protocols. During the study, participants will undergo various assessments including monitoring for serious adverse events within 7 days after the procedure, evaluation of acute procedural success, and follow-up measures at 60 days and 12 months to assess durability of pulmonary vein isolation and freedom from atrial arrhythmia. The study will also include baseline and follow-up evaluations to track safety and effectiveness outcomes, with a total participation duration of up to one year for some participants.
CONDITIONS
Brief Title
Ablation With the PFA System With a Large-Area Focal Catheter for the Treatment of Persistent Atrial Fibrillation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of recurrent symptomatic paroxysmal atrial fibrillation (Phase A) or persistent atrial fibrillation (Phases A, B, C) confirmed by physician's note and ECG documentation within 12 months prior to enrollment
- Failure or intolerance of at least one antiarrhythmic drug (Class I - IV) for atrial fibrillation
- Age between 18 and 75 years on the day of enrollment
- Indicated for an ablation procedure according to society guidelines or study site practice
- Willing and able to provide informed consent and participate in baseline and follow-up evaluations for the full study duration
You will not qualify if you...
- Long-standing persistent atrial fibrillation lasting more than 1 year
- Atrial fibrillation caused by electrolyte imbalance, thyroid disease, alcohol abuse, or other reversible/non-cardiac causes
- Previous cardiac ablation or surgical procedures including left atrial appendage device or valvular procedures
- Planned left atrial appendage closure or implantation of pacemaker, biventricular pacemaker, or implantable cardiac defibrillator during study
- Presence of permanent pacemaker or defibrillator that cannot be programmed during ablation
- Inability to stop antiarrhythmic drugs for reasons other than atrial fibrillation, including Wolff-Parkinson-White syndrome or ventricular tachycardia history
- Presence of inferior vena cava filters, interatrial baffles or patches, pulmonary vein stents, or pulmonary vein stenosis
- Pre-existing hemidiaphragmatic paralysis, atrial or ventricular septal defect closure, or atrial myxoma
- Mechanical or biological prosthetic heart valves
- Significant valvular disease, pericarditis, rheumatic heart disease, or recent thromboembolic events
- Major cardiac events or surgeries within 3 months prior to ablation
- New York Heart Association Class IV heart failure
- Left ventricular ejection fraction ≤35% within 6 months prior to enrollment
- Hypertrophic cardiomyopathy, primary pulmonary hypertension, symptomatic hypotension
- Blood platelet disorders
- Contraindications to systemic anticoagulation or imaging with CT/MRI
- Sensitivity to contrast media not controlled by premedication
- Women who are pregnant, breastfeeding, or not using reliable birth control
- Participation in other conflicting research
- Serious or untreated medical conditions that interfere with participation or assessment, including severe lung or kidney disease, recent cancer, esophageal disorders, active infection, psychological conditions, or life expectancy less than 1 year
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Procedure day plus 7 days
Participants receive pulsed field ablation treatment with a large-area focal catheter for persistent atrial fibrillation.
1 procedure visit and approximately 1 follow-up visit within 7 days
Duration - Up to 12 months
Participants are monitored for safety and effectiveness outcomes including 60-day chronic pulmonary vein isolation durability and 12-month freedom from atrial arrhythmia.
Visits at 60 days and 12 months post-procedure
Trial Site Locations
Total: 3 locations
1
KBC Split
Split, Croatia
Actively Recruiting
2
St. Anne's University Hospital
Brno, Czechia
Not Yet Recruiting
3
Homolka
Prague, Czechia
Not Yet Recruiting
Research Team
T
Tine Wouters
V
Vikramaditya Mediratta
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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