Mvz Ccb Am Agaplesion Markus Krankenhaus
Frankfurt, 60431, Germany
Location status: Recruiting
NCT Number: NCT07459387
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Frankfurt, 60431, Germany
Location status: Recruiting
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.
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.
Exclusion criteria
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.
Time frame: 12 month
Assessment of freedom from any atrial tachyarrhythmia (ATa) after the blanking period.
Time frame: 12 Months
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
Time frame: 12 Months
Comparison of different workflows for the PFA ablation procedure and the effects on outcomes.
Time frame: 12 Months
Analysis of repeat ablation procedures after an index PFA ablation with focus on lesion durability and type of a
Contact information is provided by the study sponsor or research team.
Cardioangiologisches Centrum Bethanien
Other
REVOLUTIONARY Registry
Acronym: REVOLUTIONARY
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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