PULSE PVC Registry: Multicenter Study on Focal Pulsed Field Ablation for Premature Ventricular Contractions
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Premature Ventricular Contraction (PVC), Pulsed Field Ablation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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.
Overview
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.
Detailed description
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.
Primary outcome measures
- Freedom from clinically significant PVCs at 6-month follow-up [Time frame: through study completion, an average of 6 months]
Secondary outcome measures (2)
- Acute Procedural Success [Time frame: Day 0 to Day 2 (during hospital stay)]
- Periprocedural Complication Rate [Time frame: Day 0 to Day 2 (hospital stay)]
Eligibility criteria
Inclusion criteria
- Patients with symptomatic PVCs who underwent focal monopolar biphasic PFA
- Use of Centauri Generator system
- Minimum 3-month clinical follow-up at time of data entry
Exclusion criteria
- Incomplete procedural or follow-up data
- Patients receiving exclusively RF ablation
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- Zentralklinik Bad Berka — Bad Berka
Identifiers
NCT: NCT07003412 · 23333/2024/62