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

March 5, 2026 updated by: Boris Schmidt, Cardioangiologisches Centrum Bethanien

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Boris Schmidt, Prof.Dr.med.
  • Phone Number: 004906909450280
  • Email: b.schmidt@ccb.de

Study Locations

  • Germany
      • Frankfurt, Germany, 60431
        • Recruiting
        • Mvz Ccb Am Agaplesion Markus Krankenhaus
        • Contact:
          • Boris Schmidt, Prof.Dr.med
          • Phone Number: 0049699450280
          • Email: b.schmidt@ccb.de

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: single arm
single arm registry
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy - Freedom from Arrhythmia
Time Frame: 12 month
Assessment of freedom from any atrial tachyarrhythmia (ATa) after the blanking period.
12 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: 12 Months
2) Description of the incidence of major adverse cardiovascular events (MACE) during or after the ablation.
12 Months
Procedural efficacy
Time Frame: 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
12 Months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subanalysis
Time Frame: 12 Months
Comparison of different workflows for the PFA ablation procedure and the effects on outcomes.
12 Months
Subanalysis - Performance
Time Frame: 12 Months
Analysis of repeat ablation procedures after an index PFA ablation with focus on lesion durability and type of a
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cardioangiologisches Centrum Bethanien

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 7, 2025

Primary Completion (Estimated)

October 7, 2027

Study Completion (Estimated)

October 7, 2027

Study Registration Dates

First Submitted

January 29, 2026

First Submitted That Met QC Criteria

March 5, 2026

First Posted (Actual)

March 9, 2026

Study Record Updates

Last Update Posted (Actual)

March 9, 2026

Last Update Submitted That Met QC Criteria

March 5, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Protocol V1.1
  • V/1/sja/scf/akm 2025-4080-evBO (Other Identifier: EC Hessen)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Symptomatic Atrial Fibrillation

Clinical Trials on PFA Ablation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritius

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe