Actively Recruiting
BaLloon-based PFA Ablation poST Approval Outcomes for PAF and PersAF
Led by Abbott Medical Devices · Updated on 2026-04-08
300
Participants Needed
22
Research Sites
85 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is designed to obtain real-world clinical evidence on the safety and effectiveness of the Volt PFA System in various use cases, with a sub study designed to address additional clinical evidence needs in electrophysiology.
CONDITIONS
Official 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 atrial fibrillation (PAF) or persistent atrial fibrillation (PersAF) confirmed by physician notes and ECG or Holter monitoring
- Scheduled to undergo a first-time ablation procedure with the Volt PFA Catheter due to symptomatic PAF or PersAF that is resistant, intolerant, or contraindicated to at least one Class I-IV antiarrhythmic drug
- At least 18 years of age
- Able and willing to follow all trial requirements including pre-procedure, post-procedure, and follow-up testing
- Provided written informed consent as approved by the Institutional Review Board or Ethics Committee
You will not qualify if you...
- Arrhythmia caused by reversible conditions such as thyroid disorders, acute alcohol intoxication, electrolyte imbalance, severe untreated sleep apnea, or recent major surgery within 90 days
- Presence of cardiac thrombus
- Left ventricular ejection fraction less than 35% within the past year
- New York Heart Association class III or IV heart failure
- Pregnant, nursing, or planning pregnancy during the follow-up period
- Ventriculotomy or atriotomy within 30 days before procedure
- Recent myocardial infarction, acute coronary syndrome, PCI, or valve/coronary bypass surgery within 90 days
- Unstable angina
- Stroke or transient ischemic attack within 90 days
- Heart disease expecting corrective surgery within 180 days after procedure
- History of blood clotting or bleeding disorders
- Contraindications to long-term anti-thromboembolic therapy or inability to receive adequate anticoagulation
- Previous left atrial surgical or catheter ablation procedures, including left atrial appendage closure device
- Severe mitral regurgitation or prior mitral/tricuspid valve repair or replacement
- Presence of prosthetic valves, myxoma, interatrial baffle or patch, pulmonary vein stents or stenosis
- Rheumatic heart disease or hypertrophic cardiomyopathy
- Diagnosed amyloidosis or atrial 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 months follow-up
- Medical, anatomical, social, or psychological conditions limiting study participation or compliance
- Individuals without legal authority or unable to read or write
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 22 locations
1
Ordensklinikum Linz Elisabethinen
Linz, Austria, 4020
Actively Recruiting
2
AZ Sint Jan
Bruges, Belgium, 8000
Not Yet Recruiting
3
UZ Brussel
Brussels, Belgium, 1090
Not Yet 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
Not Yet 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
Not Yet 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
CONTACT
C
Christine Sasaridis
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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