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