An observational study in Premature Ventricular Contraction (PVC) and Pulsed Field Ablation, sponsored by Zentralklinik Bad Berka. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Zentralklinik Bad Berka · Observational
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.
102 studies on the registry are indexed under Ventricular Premature Complexes; 32 are open to participants now.
This study's enrollment of 200 is above the median of 125 across 39 observational studies indexed under Ventricular Premature Complexes.
Browse Ventricular Premature Complexes studies →Zentralklinik Bad Berka is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
he study population consists of adult patients (age ≥18 years) with symptomatic premature ventricular contractions undergoing focal monopolar biphasic pulsed field ablation. All patients included must have been treated with the Centauri Generator system and have a minimum of 3 months of follow-up data available at the time of registry entry. The population is expected to be heterogeneous, including patients with and without structural heart disease, and PVCs originating from various anatomical sites. Patients will be enrolled across multiple European electrophysiology centers with varying procedural practices, enhancing the generalizability of the findings.
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Exclusion Criteria:
Freedom from clinically significant PVCs at 6-month follow-up
Clinically significant PVCs are defined as a PVC burden ≥5% on 24-hour Holter ECG. The primary efficacy endpoint is the proportion of patients who achieve a reduction in PVC burden to \<5% at 6 months following pulsed field ablation (PFA). PVC burden will be quantified using standardized 24-hour Holter recordings. Patients must not be on any new antiarrhythmic medication during this period to be considered a true efficacy responder.
Time frame: through study completion, an average of 6 months
Acute Procedural Success
Acute procedural success is defined as complete elimination of the targeted PVC morphology by the end of the ablation procedure, confirmed by the absence of spontaneous or inducible PVCs following programmed stimulation and/or isoproterenol challenge. Early PVC burden reduction is assessed via telemetry and 24-hour Holter monitoring performed during hospitalization. ≥80% reduction in PVC burden during the first 48 hours post-ablation is considered an early indicator of treatment efficacy.
Time frame: Day 0 to Day 2 (during hospital stay)
Periprocedural Complication Rate
Procedure-related complications occurring during the hospital stay will be systematically recorded from the end of the procedure until discharge (typically Day 0 to Day 2). These include vascular complications (e.g., access-site hematoma, iliac artery dissection), conduction disturbances (e.g., transient or persistent right bundle branch block), coronary vasospasm, and cerebrovascular events.
Time frame: Day 0 to Day 2 (hospital stay)
Plan to share: Undecided — The decision regarding IPD sharing is currently under review and will depend on institutional policies, ethical approvals.
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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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