Clinical trial NCT07003412: PULSE PVC Registry: Multicenter Study on Focal Pulsed Field Ablation for Premature Ventricular Contractions
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.
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Premature Ventricular Contraction (PVC)
Pulsed Field Ablation
Lead sponsor: Zentralklinik Bad Berka
Sponsor class: OTHER
First posted: 2025-06-04
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

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

Primary outcomes:
measure: Freedom from clinically significant PVCs at 6-month follow-up
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
measure: Acute Procedural Success
timeFrame: Day 0 to Day 2 (during hospital stay)
measure: Periprocedural Complication Rate
timeFrame: Day 0 to Day 2 (hospital stay)
Other outcomes:
Locations:
city: Bad Berka
country: Germany
facility: Zentralklinik Bad Berka
state: Thüringen
Study officials:
affiliation: Zentralklinikum Bad berka
name: J. Christoph Geller, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: Zentralklinik Bad Berka
name: Santi Raffa, Dr.
role: STUDY_DIRECTOR
References: