BaLloon-based PFA Ablation poST Approval Outcomes for PAF and PersAF

Recruiting now · Not applicable

Conditions studied: Paroxysmal AF, Atrial Arrhythmia, Atrial Fibrillation, Persistent Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT07181590

Run by

Abbott Medical Devices

People needed

300

Starts

2025-12-11

Expected to finish

2027-08-01

Last updated by the study team

2026-05-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Documented symptomatic PAF or PersAF. Documentation requirements are as follows:
• Paroxysmal:
• Physician's note indicating recurrent self-terminating AF AND
• One electrocardiographically documented PAF episode within 12 months prior to enrollment.
• Persistent: Continuous AF sustained beyond 7 days and less than 1 year that is documented by
• Physician's note, AND either
• 24-hour Holter within 360 days prior to enrollment, showing continuous AF, OR
• Two electrocardiograms (from any form of rhythm monitoring) showing continuous AF:
• That are taken at least 7 days apart but less than 12 months apart
• If electrograms are more than 12 months apart, there must be one or more Sinus Rhythm recordings in between or within 12 months prior to consent/enrollment
• The most recent electrocardiogram must be within 180 days of enrollment.
• NOTE: Documented evidence of the AF episode must either be continuous AF on a 12-lead ECG or include at least 30 seconds of AF from another ECG device.
• Plans to undergo a de novo ablation procedure with the Volt PFA Catheter due to symptomatic PAF or PersAF and is refractory, intolerant, or contraindicated to at least one Class I-IV AAD medication
• At least 18 years of age
• Able and willing to comply with all trial requirements including pre-procedure, post- procedure, and follow-up testing and requirements
• Informed of the nature of the trial, agreed to its provisions, and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee (IRB/EC) of the respective clinical trial site.

You may not qualify if…

• Arrhythmia due to reversible causes including thyroid disorders, acute alcohol intoxication, electrolyte imbalance, severe untreated sleep apnea, and other major surgical procedures in the preceding 90 days
• Known presence of cardiac thrombus
• Known Left ventricular ejection fraction < 35% as assessed with echocardiography within 360 days of index procedure
• New York Heart Association (NYHA) class III or IV heart failure
• Pregnant, nursing, or planning to become pregnant during the clinical investigation follow-up period
• Patients who have had a ventriculotomy or atriotomy within the preceding 30 days of procedure
• Myocardial infarction (MI), acute coronary syndrome, percutaneous coronary intervention (PCI), or valve or coronary bypass grafting surgery within preceding 90 days
• Unstable angina
• Stroke or TIA (transient ischemic attack) within the last 90 days
• Heart disease in which corrective surgery is anticipated within 180 days after procedure
• History of blood clotting or bleeding abnormalities including thrombocytosis, thrombocytopenia, bleeding diathesis, or suspected anti-coagulant state
• Contraindication to long term anti-thromboembolic therapy
• Patient unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation
• Previous left atrial surgical or left atrial catheter ablation procedure (including LAA closure device)
• Severe mitral regurgitation (regurgitant volume ≥ 60 mL/beat, regurgitant fraction ≥ 50%, and/or effective regurgitant orifice area ≥ 0.40cm2).
• Previous tricuspid or mitral valve replacement or repair
• Patients with prosthetic valves
• Patients with a myxoma
• Patients with an interatrial baffle or patch as the transseptal puncture could persist and produce an iatrogenic atrial shunt
• Stent, constriction, or stenosis in a pulmonary vein
• Rheumatic heart disease
• Hypertrophic cardiomyopathy
• Diagnosed with amyloidosis or atrial amyloidosis
• Active systemic infection
• Renal failure requiring dialysis

Where it is running

• Karolinska University Hospital Huddinge — Stockholm, Sweden (enrolling)
• AZ Sint Jan — Bruges, Belgium (enrolling)
• UZ Brussel — Brussels, Belgium (enrolling)
• Rigshospitalet — Copenhagen, Denmark (enrolling)
• Hôpital Pitié Salpetrière — Paris, France (enrolling)
• Hopital Haut Leveque — Pessac, France (enrolling)
• Clinique Pasteur Toulouse — Toulouse, France (enrolling)
• Herz-und Diabetes Zentrum NRW — Bad Oeynhausen, Germany (enrolling)
• Medizinische Einrichtungen der Universität zu Köln — Cologne, Germany (enrolling)
• Asklepios Klinik St. Georg — Hamburg, Germany (enrolling)
• TUM Klinikum - Deutsches Herzzentrum München — München, Germany (enrolling)
• Mater Private Hospital — Dublin, Ireland (enrolling)
• Az. Osp.Universitaria Osp.Riuniti Umberto I-Lancisi-Salesi — Ancona, Italy (enrolling)
• Centro Cardiologico Monzino — Milan, Italy (enrolling)
• Ordensklinikum Linz Elisabethinen — Linz, Austria (enrolling)
• St. Antonius Ziekenhuis — Nieuwegein, Netherlands (enrolling)
• National Institute of Cardiology Warsaw — Warsaw, Poland (enrolling)
• ULS de Lisboa Ocidental — Lisbon, Portugal (enrolling)
• Hospital Universitario A Coruña — A Coruña, Spain (enrolling)
• Hospital Universitario Doce de Octubre — Madrid, Spain (enrolling)
• Hospital Universitari i Politècnic La Fe — Valencia, Spain (enrolling)
• Universitair Medisch Centrum Groningen — Groningen, Netherlands

Full record on ClinicalTrials.gov

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