REVOLUTIONARY Registry
Phase: NA
Conditions: Treatment of Atrial Fibrilation, Symptomatic Atrial Fibrillation
Sponsor: Cardioangiologisches Centrum Bethanien

 
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REal-world Valued Outcomes of a noveL balloon-in-basket pUlsed 
field ablaTION catheter for Atrial fibrillation RegistrY – the 
REVOLUTIONARY Registry 
 
 
 
Clinical Investigational Plan 
Version 1.1 
August 24th 2025 
Principal Investigator: Prof. Dr. Boris Schmidt 
 
 
 

 
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1. Synopsis 
 
Background: Real world clinical evidence using novel balloon-in-basket pulsed 
field ablation (PFA) catheter for atrial fibrillation (AF) ablation does not exist. In 
particular, data on acute as well as longer term outcomes from multi-center 
experience is missing. 
 
Aim: To describe real-world adaption, work-flow data as well as procedural and 
follow-up outcomes after PFA guided AF ablation in early European users. 
 
Methods: 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. 
 
 

 
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Background 
In 2025, the new balloon-in- basket pulsed field ablation (PFA) catheter using the 
VOLT (Abbott) technology was released to commercial clinical use in Europe. 
Published data is limited to only the feasibility study and the just recently 
published CE-Mark study (1,2). Real-world clinical evidence using this novel 
balloon-in-basket PFA catheter for atrial fibrillation (AF) ablation providing 
information from large patient populations does not exist. In particular, data on 
acute procedural and longer term outcome from multi-center experience are 
missing. 
 
 
Aim of the Study 
To 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. 
 
Design 
A prospective multi center registry will be conducted assessing REal-world 
Valued Outcomes of a noveL balloon-in-basket pUlsed field ablaTION catheter 
for Atrial fibrillation RegistrY – the REVOLUTIONARY Registry 
 

 
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High volume PFA centers from Europe and Australia will collect data on center 
characteristics, demographic patient information, procedural metrics, safety and 
efficacy parameters as well as 12 months clinical outcome with regards to 
freedom from atrial tachyarrhythmia and major adverse cardiovascular events 
(MACE).  
 
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  

 
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- 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 
 
Procedural Workflow 
All procedures will be carried out as per center’s standard. This includes sedation 
protocols, vascular and transseptal access, mapping as well as ablation 
strategies. Data will be collected accordingly to analyze real-world clinical use. 
 
Endpoints 
The analysis will focus on various endpoints.  
1) Assessment of 6 months and 12 months clinical success rate defined as 
freedom from any atrial tachyarrhythmia (ATa), including AF, atrial flutter (AFL), 
or atrial tachycardie (AT) after the blanking period. 
2) Description of the incidence of major adverse cardiovascular events (MACE) 
during or after the ablation. 
3) Evolution of procedural metrics (procedure time, fluoroscopy time, safety) 
during the adoption of the technology across different centers and operators. 

 
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4) Comparison of different workflows for the PFA ablation procedure and the 
effects on outcomes. 
5) Analysis of repeat ablation procedures after an index PFA ablation with focus 
on lesion durability and type of arrhythmia recurrence. 
Number of Patients 
It is expected that up to 1000 patients from at least 3 European and Australian 
centers will enter the registry. 
 
Timeline 
This is a prospective study. Time of recruitment is planned for up to 12 months, 
followed by 12 months of follow up. After database cleaning and plausibility 
checks statistical analysis will be carried out.   
 
Statistical analysis 
The statistical analysis of this registry study will be primarily descriptive in 
nature, reflecting the observational design of the investigation. Baseline 
demographic and clinical characteristics of enrolled patients will be summarized 
using appropriate descriptive statistics: continuous variables will be presented 
as mean, standard deviation, median, interquartile range, minimum, and 
maximum, while categorical variables will be summarized as counts and 
percentages. 

 
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For the primary endpoints, the analysis will focus on estimating the frequency 
and distribution of outcomes of interest within the study population. Secondary 
analyses will explore associations between patient characteristics, treatment 
patterns, and outcomes. Where appropriate, subgroup analyses will be 
conducted to assess potential differences across clinically relevant patient 
groups (e.g., by age, sex, disease severity, or treatment modality). 
 
Exploratory inferential analyses may include regression modeling (e.g., logistic 
regression, Cox proportional hazards models) to adjust for potential confounding 
factors and to identify predictors of clinical outcomes. Missing data will be 
handled using established statistical approaches, such as multiple imputation or 
sensitivity analyses, depending on the extent and pattern of missingness. 
 
All statistical tests will be two-sided, and p-values <0.05 will be considered 
statistically significant. However, given the exploratory character of the registry, 
emphasis will be placed on the estimation of effect sizes and confidence intervals 
rather than formal hypothesis testing. Statistical analyses will be performed 
using validated statistical software. 
 
 

 
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Data collection and Data protection 
Data will be collected by each participating site in a digital database. Before data 
sharing data will anonymized to render identification of individual patients 
impossible. Data will be transferred to a protected server at the 
Cardioangiologisches Centrum Bethanien via a secure internet connection. 
 
References: 
1.  
Sanders P, Healy S, Emami M, Kotschet E, Miller A, Kalman JM. Initial 
Clinical Experience with the Balloon-in-Basket Pulsed Field Ablation 
System: Acute Results of the VOLT CE Mark Feasibility Study. Europace. 
2024 May;  
2.  
Tilz RR, Chierchia GB, Gunawardene M, Sanders P, Haqqani H, Kalman J, 
Healy S, Puererfellner H, Neuzil P, Osca Asensi J, Loh P, Reddy VY, Knecht 
S, Jesser E, Dirckx N, Miller A, Walker D, Lakkireddy D. Safety and 
Effectiveness of the First Balloon-in-Basket Pulsed Field Ablation System 
for the Treatment of Atrial Fibrillation: VOLT CE Mark Study 6-Month 
Results. Europace. 2025 Mar;