RecruitingNot ApplicableNCT07181590

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

Sponsor

Abbott Medical Devices

Enrollment

300 participants

Start Date

Dec 11, 2025

Study Type

INTERVENTIONAL

Conditions

Atrial Fibrillation Atrial Arrhythmia Persistent Atrial Fibrillation Paroxysmal AF

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is collecting real-world outcomes data on patients who have had a catheter ablation procedure for atrial fibrillation (AFib) — an irregular heart rhythm — using a balloon-based technology called pulsed field ablation (PFA). It aims to understand how well this new technique works in everyday clinical practice. **You may be eligible if...** - You have been diagnosed with paroxysmal AFib (episodes that start and stop on their own) or persistent AFib (continuous AFib lasting more than 7 days but less than 1 year) - Your AFib has been confirmed by heart rhythm monitoring - You and your doctor have decided that catheter ablation using the PFA balloon system is appropriate for you **You may NOT be eligible if...** - You have long-standing persistent AFib (lasting more than a year) - You have previously had an ablation for AFib using this specific device type - You have other serious heart conditions that make this procedure inappropriate Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEPulsed Field Ablation

Pulsed Field Ablation using the Volt PFA System

Locations(22)

Ordensklinikum Linz Elisabethinen

Linz, Austria

AZ Sint Jan

Bruges, Belgium

UZ Brussel

Brussels, Belgium

Rigshospitalet

Copenhagen, Denmark

Hôpital Pitié Salpetrière

Paris, France

Hopital Haut Leveque

Pessac, France

Clinique Pasteur Toulouse

Toulouse, France

Herz-und Diabetes Zentrum NRW

Bad Oeynhausen, Germany

Medizinische Einrichtungen der Universität zu Köln

Cologne, Germany

Asklepios Klinik St. Georg

Hamburg, Germany

TUM Klinikum - Deutsches Herzzentrum München

München, Germany

Mater Private Hospital

Dublin, Ireland

Az. Osp.Universitaria Osp.Riuniti Umberto I-Lancisi-Salesi

Ancona, Italy

Centro Cardiologico Monzino

Milan, Italy

Universitair Medisch Centrum Groningen

Groningen, Netherlands

St. Antonius Ziekenhuis

Nieuwegein, Netherlands

National Institute of Cardiology Warsaw

Warsaw, Poland

ULS de Lisboa Ocidental

Lisbon, Portugal

Hospital Universitario A Coruña

A Coruña, Spain

Hospital Universitario Doce de Octubre

Madrid, Spain

Hospital Universitari i Politècnic La Fe

Valencia, Spain

Karolinska University Hospital Huddinge

Stockholm, Sweden

View Full Details on ClinicalTrials.gov

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NCT07181590

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