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

• Conditions: Pulsed Field Ablation; Premature Ventricular Contraction (PVC)

• Registration Number: NCT07003412
• Lead Sponsor: Zentralklinik Bad Berka

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.

Study Timeline

• Study Start: 2024-06-01
• Status Verified: 2025-05
• Study First Submitted: 2025-05-18
• Study First Submitted QC: 2025-05-25
• Last Update Submitted: 2025-05-25
• Study First Posted: 2025-06-04
• Last Update Posted: 2025-06-04
• Primary Completion: 2025-12-01
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Freedom from clinically significant PVCs at 6-month follow-up	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 Outcome Measures

Name	Time	Method
Acute Procedural Success	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.
Periprocedural Complication Rate	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.

Trial Locations

Locations (1)

Zentralklinik Bad Berka; 🇩🇪 Bad Berka, Thüringen, Germany