Real-world outcomes of a novel balloon-in-basket pulsed-field ablation catheter for atrial fibrillation
REVOLUTIONARY Registry
This registry will collect real-world data to see how a new balloon-in-basket pulsed-field ablation catheter performs for adults with symptomatic atrial fibrillation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cardioangiologisches Centrum Bethanien Academic / other |
| Locations | 1 site (Frankfurt) |
| Trial ID | NCT07459387 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18 years) with symptomatic atrial fibrillation who undergo AF ablation using the VOLT balloon-in-basket PFA system at participating European centers and can provide informed consent.
Not a fit: Patients with left atrial diameter >60 mm, severe mitral valve disease or prior mitral surgery, contraindications to ablation or anticoagulation, intracardiac thrombus, untreated reversible causes of AF, pregnancy, breastfeeding, or active systemic infection are unlikely to be included or to benefit.
Why it matters
Potential benefit: If successful, this approach could offer a faster, more tissue-selective ablation method with improved safety and more streamlined procedural workflows for treating atrial fibrillation.
How similar studies have performed: Other pulsed-field ablation programs and registries have reported promising safety and efficacy signals, but the balloon-in-basket VOLT configuration remains a newer device with limited published real-world data.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Frankfurt
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.