Actively Recruiting
BaLloon-based PFA Ablation poST Approval Outcomes for PAF and PersAF
Led by Abbott Medical Devices · Updated on 2026-05-26
300
Participants Needed
22
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the Volt PFA System in people with paroxysmal and persistent atrial fibrillation who have symptoms and have not responded to drug treatment. The study aims to gather real-world evidence on the safety and effectiveness of this balloon-based pulsed field ablation device, with additional clinical information gathered in a sub study focused on electrophysiology. Participants will undergo a new ablation procedure using the Volt PFA Catheter to treat their atrial fibrillation. This interventional study involves applying pulsed field ablation with the Volt PFA System to target the affected heart tissue. The procedure is performed once, and patients will be monitored for outcomes related to the device and treatment. Throughout the study, participants will be observed for serious adverse events within 7 days after the ablation procedure. Effectiveness will be measured by the absence of atrial fibrillation, atrial flutter, or atrial tachycardia recurrence over 12 months. Also, acute procedural success is confirmed during the procedure by checking electrical block in all targeted pulmonary veins. Participants must comply with follow-up testing and visits throughout the study period ending in 2027.
CONDITIONS
Brief Title
BaLloon-based PFA Ablation poST Approval Outcomes for PAF and PersAF
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Documented symptomatic paroxysmal or persistent atrial fibrillation with electrocardiographic evidence within specified time frames
- Plans to undergo a first-time ablation procedure with the Volt PFA Catheter due to symptomatic atrial fibrillation refractory or intolerant to at least one Class I-IV antiarrhythmic drug
- At least 18 years of age
- Able and willing to comply with all trial procedures and follow-up requirements
- Provided informed consent as approved by an ethics committee
You will not qualify if you...
- Arrhythmia caused by reversible conditions such as thyroid disorders, acute alcohol intoxication, electrolyte imbalance, or untreated severe sleep apnea
- Presence of cardiac thrombus
- Left ventricular ejection fraction below 35% within the past year
- New York Heart Association class III or IV heart failure
- Pregnant, nursing, or planning pregnancy during the study follow-up
- Recent ventriculotomy or atriotomy within 30 days
- Recent heart attack, acute coronary syndrome, or heart surgery within 90 days
- Unstable angina or stroke/TIA within 90 days
- Anticipated corrective heart surgery within 180 days after procedure
- History of blood clotting or bleeding disorders
- Contraindications to long-term anticoagulation or inability to receive heparin
- Previous left atrial surgical or catheter ablation procedures
- Severe mitral regurgitation or valve replacements/repairs
- Prosthetic heart valves or cardiac myxoma
- Interatrial baffle or patch
- Pulmonary vein stenosis or constriction
- Rheumatic heart disease or hypertrophic cardiomyopathy
- Diagnosed amyloidosis
- Active systemic infection
- Renal failure requiring dialysis
- Severe pulmonary disease causing chronic symptoms
- Implanted left atrial appendage closure device
- Participation in another conflicting clinical study
- Unlikely to survive 12-month follow-up
- Other medical, social, or psychological conditions limiting participation or compliance
- Lack of legal authority or inability to read/write
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 - During procedure
Participants undergo Pulsed Field Ablation using the Volt PFA System as a treatment for atrial fibrillation.
1 procedure visit (in-person)
Duration - Up to 12 months
Participants are monitored for safety and effectiveness outcomes including adverse events and recurrence of atrial fibrillation for up to 12 months after the ablation procedure.
Approximately 6 post-procedure visits
Trial Site Locations
Total: 22 locations
1
Ordensklinikum Linz Elisabethinen
Linz, Austria, 4020
Actively Recruiting
2
AZ Sint Jan
Bruges, Belgium, 8000
Actively Recruiting
3
UZ Brussel
Brussels, Belgium, 1090
Actively Recruiting
4
Rigshospitalet
Copenhagen, Denmark, 2100
Actively Recruiting
5
Hôpital Pitié Salpetrière
Paris, France, 75013
Actively Recruiting
6
Hopital Haut Leveque
Pessac, France, 33600
Actively Recruiting
7
Clinique Pasteur Toulouse
Toulouse, France, 31076
Actively Recruiting
8
Herz-und Diabetes Zentrum NRW
Bad Oeynhausen, Germany, 32545
Actively Recruiting
9
Medizinische Einrichtungen der Universität zu Köln
Cologne, Germany, 50937
Actively Recruiting
10
Asklepios Klinik St. Georg
Hamburg, Germany, 20099
Actively Recruiting
11
TUM Klinikum - Deutsches Herzzentrum München
München, Germany, 80636
Actively Recruiting
12
Mater Private Hospital
Dublin, Ireland, DUBLIN 7
Actively Recruiting
13
Az. Osp.Universitaria Osp.Riuniti Umberto I-Lancisi-Salesi
Ancona, Italy, 60126
Actively Recruiting
14
Centro Cardiologico Monzino
Milan, Italy, 20138
Actively Recruiting
15
Universitair Medisch Centrum Groningen
Groningen, Netherlands, 9713 GZ
Not Yet Recruiting
16
St. Antonius Ziekenhuis
Nieuwegein, Netherlands, 3435 CM
Actively Recruiting
17
National Institute of Cardiology Warsaw
Warsaw, Poland, 04-628
Actively Recruiting
18
ULS de Lisboa Ocidental
Lisbon, Portugal, 2799-523
Actively Recruiting
19
Hospital Universitario A Coruña
A Coruña, Spain, 15006
Actively Recruiting
20
Hospital Universitario Doce de Octubre
Madrid, Spain, 28041
Actively Recruiting
21
Hospital Universitari i Politècnic La Fe
Valencia, Spain, 46026
Actively Recruiting
22
Karolinska University Hospital Huddinge
Stockholm, Sweden, 14186
Actively Recruiting
Research Team
K
Karolilen Timmermans
C
Christine Sasaridis
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here