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

NCT ID: NCT07003412

Last Updated: 2025-06-10

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2026-04-01

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.

Conditions

Premature Ventricular Contraction (PVC); Pulsed Field Ablation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zentralklinik Bad Berka

OTHER

Sponsor Role: lead

Responsible Party

Ahmad Keelani

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

J. Christoph Geller, Prof. Dr.

Role: STUDY_DIRECTOR

Zentralklinikum Bad berka

Santi Raffa, Dr.

Role: STUDY_DIRECTOR

Zentralklinik Bad Berka

Locations

Zentralklinik Bad Berka

Bad Berka, Thuringia, Germany

Countries

Germany

Other Identifiers

23333/2024/62

Identifier Type: -

Identifier Source: org_study_id