RecruitingNot ApplicableNCT07459387

REal-world Valued Outcomes of a noveL Balloon-in-basket pUlsed Field ablaTION Catheter for Atrial Fibrillation RegistrY

REVOLUTIONARY Registry


Sponsor

Cardioangiologisches Centrum Bethanien

Enrollment

1,000 participants

Start Date

Oct 7, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

describe real-world adaption, work-flow data as well as procedural and follow-up outcomes after balloon-in-basket guided PFA for AF in early European users.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study collects real-world data on patients who undergo catheter ablation for atrial fibrillation (an irregular heart rhythm) using a new balloon-in-basket device called the VOLT PFA system. Ablation uses energy to create small scars in the heart tissue to stop the abnormal electrical signals causing the irregular rhythm. Researchers want to understand patient outcomes in everyday clinical practice. **You may be eligible if...** - You are 18 or older - You have had atrial fibrillation treated with the VOLT PFA catheter ablation system - You are able and willing to provide informed consent **You may NOT be eligible if...** - Your left atrium (a chamber of the heart) is very enlarged (over 60 mm) - You have severe mitral valve disease or have had a valve procedure - You have a blood clot in the heart, or you cannot take blood thinners - You have untreated thyroid overactivity or reversible causes for your irregular rhythm (such as heavy alcohol use) - You have an active infection - You are pregnant or breastfeeding 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

PROCEDUREPFA Ablation

All-comer data of patients with symptomatic atrial fibrillation (AF) who underwent catheter ablation using the novel balloon-in-basket PFA catheter will be collected from European high-volume centers who were involved in the early market release of the VOLT (Abbott) technology. Data includes patient demographics, procedural metrics on safety and efficacy as well as follow-up outcome data. Learning curve characteristics and comparison on different workflows will be assessed.


Locations(1)

Mvz Ccb Am Agaplesion Markus Krankenhaus

Frankfurt, Germany

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NCT07459387