Real-world outcomes of a novel balloon-in-basket pulsed-field ablation catheter for atrial fibrillation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

A prospective, multi-center European registry will gather all-comer data from high-volume early users of the VOLT balloon-in-basket pulsed-field ablation (PFA) system. The registry will record patient demographics, procedural workflow metrics, safety events, acute efficacy and follow-up outcomes after catheter ablation for symptomatic atrial fibrillation. Learning curve characteristics and comparisons of different workflows across centers will be analyzed. Data collection focuses on real-world adaptation and procedural and follow-up outcomes in routine clinical practice.

Why it matters

Who can join: the full rules

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

Where it's running

• Mvz Ccb Am Agaplesion Markus Krankenhaus
  Frankfurt, Germany Recruiting

Study contacts

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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.