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| ID | Type | Description | Link |
|---|---|---|---|
| V/1/sja/scf/akm 2025-4080-evBO | Other Identifier | EC Hessen |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single arm | Experimental | single arm registry |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy - Freedom from Arrhythmia | Assessment of freedom from any atrial tachyarrhythmia (ATa) after the blanking period. | 12 month |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | 2) Description of the incidence of major adverse cardiovascular events (MACE) during or after the ablation. | 12 Months |
| Procedural efficacy | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Subanalysis | Comparison of different workflows for the PFA ablation procedure and the effects on outcomes. | 12 Months |
| Subanalysis - Performance | Analysis of repeat ablation procedures after an index PFA ablation with focus on lesion durability and type of a |
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Boris Schmidt, Prof.Dr.med. | Contact | 004906909450280 | b.schmidt@ccb.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mvz Ccb Am Agaplesion Markus Krankenhaus | Recruiting | Frankfurt | 60431 | Germany |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 24, 2025 | Oct 12, 2025 |
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|
| 12 Months |
| 12 Months |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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