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

Cardioangiologisches Centrum Bethanien

Status: Enrolling

Conditions: Symptomatic Atrial Fibrillation; Treatment of Atrial Fibrilation

Treatments: Procedure: PFA Ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT07459387

Protocol V1.1

V/1/sja/scf/akm 2025-4080-evBO (Other Identifier)

Details and patient eligibility

About

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.

Full description

A prospective, multi-center registry, REal-world Valued Outcomes of a noveL balloon-in-basket pUlsed field ablaTION catheter for Atrial fibrillation RegistrY - the REVOLUTIONARY Registry - was designed. 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,000 participants in 1 patient group

single arm

Experimental group

Description:

single arm registry

Treatment:

Procedure: PFA Ablation