Skip to main content
TTrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor.
RECRUITINGINTERVENTIONAL

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

REVOLUTIONARY Registry

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: All patients who underwent an AF catheter ablation procedure using the novel balloon-in-basket VOLT PFA system will be included into the analysis. - Age ≥ 18 years - Subject is able and willing to give willing to sign a consent form Who Should NOT Join This Trial: - LA-Diameter \> 60mm - Severe mitral stenosis or regurgitation, prior mitral valve reconstruction or replacement - Any condition or disease, which is contraindication for AF ablation, up to the assessment of the investigator - Known intra-cardiac thrombus formation Any contraindication for oral anticoagulation - Any untreated or uncontrolled hyperthyroidism or other reversible causes for AF like alcoholism - Pregnant or breastfeeding woman or woman of childbearing potential not on adequate birth control - Active systemic infection Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: All patients who underwent an AF catheter ablation procedure using the novel balloon-in-basket VOLT PFA system will be included into the analysis. * Age ≥ 18 years * Subject is able and willing to give informed consent Exclusion Criteria: * LA-Diameter \> 60mm * Severe mitral stenosis or regurgitation, prior mitral valve reconstruction or replacement * Any condition or disease, which is contraindication for AF ablation, up to the assessment of the investigator * Known intra-cardiac thrombus formation Any contraindication for oral anticoagulation * Any untreated or uncontrolled hyperthyroidism or other reversible causes for AF like alcoholism * Pregnant or breastfeeding woman or woman of childbearing potential not on adequate birth control * Active systemic infection

Treatments Being Tested

PROCEDURE

PFA 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