Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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. | through study completion, an average of 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. A PVC burden <5% during the first 48 hours post-ablation is considered an early indicator of treatment efficacy. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| J. Christoph Geller, Prof. Dr. | Zentralklinikum Bad berka | Study Director |
| Santi Raffa, Dr. | Zentralklinik Bad Berka | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zentralklinik Bad Berka | Bad Berka | Thuringia | Germany |
The decision regarding IPD sharing is currently under review and will depend on institutional policies, ethical approvals.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D018879 | Ventricular Premature Complexes |
| ID | Term |
|---|---|
| D005117 | Cardiac Complexes, Premature |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. | Day 0 to Day 2 (hospital stay) |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |