Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT07003412

PULSE PVC Registry: Multicenter Study on Focal Pulsed Field Ablation for Premature Ventricular Contractions

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Premature Ventricular Contraction (PVC) Arrhythmias, Cardiac Cardiac Complexes, Premature Cardiac Conduction System Disease Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pulsed Field Ablation Ventricular Premature Complexes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Zentralklinik Bad Berka

Bad Berka, Thuringia, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Freedom from clinically significant PVCs at 6-month follow-up

    Time frame: through study completion, an average of 6 months

    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.

Secondary outcomes

  1. Acute Procedural Success

    Time frame: Day 0 to Day 2 (during hospital stay)

    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.

  2. Periprocedural Complication Rate

    Time frame: Day 0 to Day 2 (hospital stay)

    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.

Sponsors and collaborators

Lead sponsor

Zentralklinik Bad Berka

Other

Registry information

Official study 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.

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jun 4, 2025
Registry last updated
Jun 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.