RecruitingNot ApplicableNCT06106594

VOLT CE Mark Study


Sponsor

Abbott Medical Devices

Enrollment

300 participants

Start Date

Oct 24, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This clinical investigation is intended to demonstrate safety and effectiveness of the Volt™ Pulsed Field Ablation (PFA) Catheter Sensor Enabled™, the Volt™ PFA Generator, Agilis™ NxT Steerable Introducer Dual-Reach™, and EnSite™ X EP System EnSite™ Pulsed Field Ablation Module (for simplicity of reference this device collection will hereafter be referred to as the Volt™ PFA system) for the treatment of symptomatic, recurrent, drug-refractory paroxysmal and persistent atrial fibrillation.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

The VOLT study is evaluating a new catheter ablation system designed to treat atrial fibrillation (AFib) — an irregular and often fast heartbeat — by electrically isolating the pulmonary veins (the most common trigger area for AFib). It is testing the safety and performance of this device as part of CE marking (European regulatory approval). **You may be eligible if...** - You are 18 or older with symptomatic atrial fibrillation (paroxysmal — episodes that stop on their own, or persistent — continuous but under 1 year) - Your AFib has been confirmed by ECG or heart monitor - You have tried and failed, cannot tolerate, or have contraindications to at least one antiarrhythmic medication - You are scheduled for a pulmonary vein isolation (catheter ablation) procedure **You may NOT be eligible if...** - You have had continuous AFib for more than 1 year - Your AFib is caused by a reversible problem (thyroid disease, alcohol, electrolyte imbalance) - There is a blood clot in your heart - Your left atrium (heart chamber) is very enlarged (≥ 5.5 cm) - Your heart pumping function is severely reduced (ejection fraction < 35%) - You have severe heart failure (NYHA class III or IV) - Your BMI is above 40 - You are pregnant 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(16)

The Prince Hospital

Chermside, Queensl, Australia

Royal Adelaide Hospital

Adelaide, Saustrl, Australia

Monash Health

Clayton, Victoria, Australia

Royal Melbourne Hospital - City Campus

Parkville, Victoria, Australia

A. ö. Krankenhaus der Elisabethinen Linz

Linz, UPR AUS, Austria

UZ Brussel

Brussels, Brussels Capital, Belgium

AZ Sint Jan

Bruges, Wflndrs, Belgium

Nemocnice Na Homolce

Prague, Cbohmia, Czechia

Medizinische Einrichtungen der Universität zu Köln

Cologne, N. RHIN, Germany

Universitätsklinikum Schleswig-Holstein - Campus Lübeck

Lübeck, Schlesw, Germany

Universitätsmedizin Berlin - Charité Campus Mitte (CCM)

Berlin, State of Berlin, Germany

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

Ancona, The Marches, Italy

UMC Utrecht

Utrecht, Utrecht, Netherlands

Hospital Universitari i Politècnic La Fe

Valencia, Valencia, Spain

Hôpital Cantonal Universitaire de Geneva

Geneva, Canton of Geneva, Switzerland

St. Bartholomew's Hospital

London, London, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06106594


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