Symptomatic Atrial Fibrillation, Treatment of Atrial Fibrilation
Conditions
Keywords
ablation, pulsed field, atrial fibrillation
Brief 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.
Detailed 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.
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.
Sponsors
Cardioangiologisches Centrum Bethanien
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy - Freedom from Arrhythmia | 12 month | Assessment of freedom from any atrial tachyarrhythmia (ATa) after the blanking period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 12 Months | 2\) Description of the incidence of major adverse cardiovascular events (MACE) during or after the ablation. |
| Procedural efficacy | 12 Months | 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 |
Countries
Germany
Contacts
CONTACTBoris Schmidt, Prof.Dr.med.
Outcome results
None listed