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NCT Number: NCT07459387

REal-world Valued Outcomes of a noveL Balloon-in-basket pUlsed Field ablaTION Catheter for Atrial Fibrillation 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mvz Ccb Am Agaplesion Markus Krankenhaus

Frankfurt, 60431, Germany

Location status: Recruiting

Location contact

Boris Schmidt, Prof.Dr.med

CONTACT

[email protected]

0049699450280

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PFA Ablation

Procedure

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.

Primary outcomes

  1. Efficacy - Freedom from Arrhythmia

    Time frame: 12 month

    Assessment of freedom from any atrial tachyarrhythmia (ATa) after the blanking period.

Secondary outcomes

  1. Adverse Events

    Time frame: 12 Months

    • Description of the incidence of major adverse cardiovascular events (MACE) during or after the ablation.
  2. 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

Other outcomes

  1. Subanalysis

    Time frame: 12 Months

    Comparison of different workflows for the PFA ablation procedure and the effects on outcomes.

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Boris Schmidt, Prof.Dr.med.

CONTACT

[email protected]

004906909450280

Sponsors and collaborators

Lead sponsor

Cardioangiologisches Centrum Bethanien

Other

Registry information

Official study title

REVOLUTIONARY Registry

Acronym: REVOLUTIONARY

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 9, 2026
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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