Treatment of Atrial FibrilationREVOLUTIONARYNCT07459387
REal-world Valued Outcomes of a noveL Balloon-in-basket pUlsed Field ablaTION Catheter for Atrial Fibrillation RegistrY
A study testing PFA Ablation in people with Treatment of Atrial Fibrilation and Symptomatic Atrial Fibrillation, run by Cardioangiologisches Centrum Bethanien at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Treatment of Atrial Fibrilation, Symptomatic Atrial Fibrillation
- What is being tested?
- PFA Ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteGermany
- Study dates
- 7 Oct 2025to 7 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Mvz Ccb Am Agaplesion Markus Krankenhaus
Frankfurt, 60431
Boris Schmidt, Prof.Dr.med, 0049699450280, b.schmidt@ccb.de
About this study
Official title: REVOLUTIONARY Registry
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.
Read the 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.
- Being tested
- PFA Ablation
- Keywords
- ablation, pulsed field, atrial fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PFA AblationProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| single arm | Experimental | single arm registry Receives: Procedure: PFA Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy - Freedom from Arrhythmia
Assessment of freedom from any atrial tachyarrhythmia (ATa) after the blanking period.
Measured: 12 month
Secondary outcomes (2)
Adverse Events
- Description of the incidence of major adverse cardiovascular events (MACE) during or after the ablation.
Measured: 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
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start7 Oct 2025
- Primary completion7 Oct 2027 (estimated)
- Study completion7 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment of Atrial FibrilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cardioangiologisches Centrum Bethanien
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Boris Schmidt, Cardioangiologisches Centrum Bethanien
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07459387
- Sponsor's protocol ID
- Protocol V1.1
- Other IDs
- V/1/sja/scf/akm 2025-4080-evBO
- Acronym
- REVOLUTIONARY
- Status last verified
- Mar 2026
- First submitted
- 29 Jan 2026
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REVOLUTIONARY Registry
- ClinicalTrials.gov ID
- NCT07459387
- Acronym / sponsor ID
- REVOLUTIONARY / Protocol V1.1
- Keywords
- ablation, pulsed field, atrial fibrillation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Cardioangiologisches Centrum BethanienUniversity, hospital or other
- Study start
- 7 Oct 2025 (actual)
- Primary completion
- 7 Oct 2027 (estimated)
- Study completion
- 7 Oct 2027 (estimated)
- First posted
- 9 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm | Experimental | Procedure: PFA Ablationsingle arm registry |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PFA AblationAll-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. | Procedure or surgery | single arm |
Primary outcome
Efficacy - Freedom from Arrhythmia
Time frame: 12 month
Assessment of freedom from any atrial tachyarrhythmia (ATa) after the blanking period.
2 secondary outcomes
Adverse Events
Time frame: 12 Months
Procedural efficacy
Time frame: 12 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PFA Ablation in people with Treatment of Atrial Fibrilation and Symptomatic Atrial Fibrillation, run by Cardioangiologisches Centrum Bethanien at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Boris Schmidt, Prof.Dr.med. (004906909450280, b.schmidt@ccb.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy - Freedom from Arrhythmia (time frame: 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.