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

Cardioangiologisches Centrum Bethanien1,000 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

1,000

Conditions

Treatment of Atrial Fibrilation Symptomatic Atrial Fibrillation

Interventions

PFA AblationPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Mvz Ccb Am Agaplesion Markus Krankenhaus

Frankfurt, Germany

RECRUITING

Outcomes

Primary Outcomes

Efficacy - Freedom from Arrhythmia

Assessment of freedom from any atrial tachyarrhythmia (ATa) after the blanking period.

Time frame: 12 month

Secondary Outcomes

Adverse Events

2\) Description of the incidence of major adverse cardiovascular events (MACE) during or after the ablation.

Time frame: 12 Months

Procedural efficacy

Evolution of procedural metrics (procedure time, fluoroscopy time, safety) during the adoption of the technology across different centers and operators. Any contraindication for oral anticoagulation

Time frame: 12 Months

Central Contacts

Boris Schmidt, Prof.Dr.med.

CONTACT

004906909450280 b.schmidt@ccb.de

Data from ClinicalTrials.gov

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