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The PULSE PVC Registry Evaluates the Safety and Efficacy of Focal PFA Using the Centauri System for Symptomatic PVCs Across European Centers, With Outcomes Stratified by Site of Origin and Compared to Historical RF Ablation Data.
The PULSE PVC Registry is a European multicenter observational study designed to assess the safety and efficacy of focal pulsed field ablation (PFA) using the Centauri Generator system in patients with symptomatic premature ventricular contractions (PVCs). The registry collects standardized procedural and follow-up data across diverse PVC origins, enabling comparisons with historical radiofrequency (RF) ablation outcomes. Data will include baseline characteristics, procedural details, complications, and long-term PVC burden reduction. Each center will obtain local ethics approval, and only anonymized data will be analyzed.
The PULSE PVC Registry is a European multicenter observational registry designed to evaluate the safety, feasibility, and midterm outcomes of focal pulsed field ablation (PFA) for the treatment of symptomatic premature ventricular contractions (PVCs). The study includes patients undergoing focal PFA using a monopolar biphasic energy system (Centauri Generator), across multiple high-volume electrophysiology centers in Europe. The registry collects detailed baseline demographics, comorbidities (e.g., hypertension, diabetes, chronic kidney disease), structural heart disease status, antiarrhythmic drug use, prior ablation history, and baseline PVC burden. Procedural characteristics include PVC mapping approach, pharmacologic testing (e.g., isoproterenol, nitroglycerin), number and type of ablation applications (PFA and/or RF), use of coronary angiography, venous system access (GCV/AIV), and fluoroscopy metrics. Outcomes assessed include: Primary outcome: Midterm clinical success, defined as a reduction in PVC burden to \<5% on follow-up (via Holter monitoring) Secondary outcomes: Acute procedural success, complication rates (e.g., coronary vasospasm, conduction disturbances, stroke, vascular complications), and recurrence patterns. Patients are stratified based on the site of origin of PVCs (e.g., RVOT subregions, LVOT, aortic cusps, papillary muscles). Follow-up includes symptom assessment, PVC burden, antiarrhythmic drug use, and mode of follow-up (telephone or in-person). The registry provides a comprehensive overview of clinical outcomes with focal PFA and enables comparison with historical radiofrequency ablation data. This registry aims to generate robust real-world evidence to inform procedural strategy, patient selection, and safety considerations in PVC ablation using pulsed field energy.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Zentralklinik Bad Berka
Bad Berka, Thuringia, Germany
Start Date
June 1, 2024
Primary Completion Date
December 1, 2025
Completion Date
April 1, 2026
Last Updated
June 10, 2025
200
ESTIMATED participants
Lead Sponsor
Zentralklinik Bad Berka
NCT07349121
NCT07354217
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT06780215