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

NCT07003412 | Enrolling By Invitation

• 1 other identifier: 23333/2024/62
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature Ventricular Contraction (PVC); Pulsed Field Ablation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Acute Procedural Success

  Day 0 to Day 2 (during hospital stay)

• Periprocedural Complication Rate

  Day 0 to Day 2 (hospital stay)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Incomplete procedural or follow-up data
• Patients receiving exclusively RF ablation

Sponsors & Collaborators

• Zentralklinik Bad Berka: lead

Study Sites (1)

Zentralklinik Bad Berka

Bad Berka, Thuringia, Germany

Location

MeSH Terms

Conditions

Ventricular Premature Complexes

Condition Hierarchy (Ancestors)

Cardiac Complexes, Premature; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• J. Christoph Geller, Prof. Dr.

  Zentralklinikum Bad berka

  STUDY DIRECTOR

• Santi Raffa, Dr.

  Zentralklinik Bad Berka

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 18, 2025
• First Posted: June 4, 2025
• Study Start: June 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: April 1, 2026
• Last Updated: June 10, 2025

Record last verified: 2025-06

Locations

DE (1)