New Balloon-Based ablation device tested in Real-World AFib patients
NCT ID NCT07181590
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is tracking 300 people with paroxysmal or persistent atrial fibrillation (AFib) who are treated with the Volt PFA System, a balloon-based device that uses pulsed field ablation to correct irregular heart rhythms. Researchers are monitoring safety—looking for serious side effects within 7 days—and effectiveness, such as freedom from AFib recurrence over 12 months. The goal is to see how well the device works in real-world settings, not just in controlled trials.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
- Active substance
- Pulsed Field Ablation using the Volt PFA System
- What this could lead to
- If successful, this could confirm that the Volt PFA System is a safe and effective option for treating atrial fibrillation in everyday medical practice.
- What could go wrong
- This is an observational study, not a controlled trial, so results may be less definitive. Risks include serious complications like heart damage or stroke, though the study aims to measure how often these occur.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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AZ Sint Jan
RECRUITINGBruges, 8000, Belgium
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Asklepios Klinik St. Georg
RECRUITINGHamburg, 20099, Germany
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Az. Osp.Universitaria Osp.Riuniti Umberto I-Lancisi-Salesi
RECRUITINGAncona, 60126, Italy
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Centro Cardiologico Monzino
RECRUITINGMilan, 20138, Italy
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Clinique Pasteur Toulouse
RECRUITINGToulouse, 31076, France
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Herz-und Diabetes Zentrum NRW
RECRUITINGBad Oeynhausen, 32545, Germany
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Hopital Haut Leveque
RECRUITINGPessac, 33600, France
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Hospital Universitari i Politècnic La Fe
RECRUITINGValencia, 46026, Spain
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Hospital Universitario A Coruña
RECRUITINGA Coruña, 15006, Spain
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Hospital Universitario Doce de Octubre
RECRUITINGMadrid, 28041, Spain
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Hôpital Pitié Salpetrière
RECRUITINGParis, 75013, France
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Karolinska University Hospital Huddinge
RECRUITINGStockholm, 14186, Sweden
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Mater Private Hospital
RECRUITINGDublin, DUBLIN 7, Ireland
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Medizinische Einrichtungen der Universität zu Köln
RECRUITINGCologne, 50937, Germany
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National Institute of Cardiology Warsaw
RECRUITINGWarsaw, 04-628, Poland
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Ordensklinikum Linz Elisabethinen
RECRUITINGLinz, 4020, Austria
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Rigshospitalet
RECRUITINGCopenhagen, 2100, Denmark
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St. Antonius Ziekenhuis
RECRUITINGNieuwegein, 3435 CM, Netherlands
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TUM Klinikum - Deutsches Herzzentrum München
RECRUITINGMünchen, 80636, Germany
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ULS de Lisboa Ocidental
RECRUITINGLisbon, 2799-523, Portugal
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UZ Brussel
RECRUITINGBrussels, 1090, Belgium
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Universitair Medisch Centrum Groningen
NOT_YET_RECRUITINGGroningen, 9713 GZ, Netherlands
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Could a new injection tame atrial fibrillation?
- Which blood thinner is safer for heart patients? a Head-to-Head test
- Can a cholesterol drug keep atrial fibrillation at bay after ablation?
- Can a One-Two punch fix a leaky heart valve and restore normal rhythm?
- Could a guided Self-Care plan tame atrial Fibrillation's return?