Focal Pulsed Field Ablation of Ventricular Tachycardia

The PULSE-VT Registry is a combined retrospective and prospective observational registry evaluating focal PFA for clinically indicated VT ablation using the Centauri™ PFA System. The Centauri system enables focal, point-by-point delivery of pulsed field energy and can be incorporated into established electroanatomical mapping workflows. This allows activation-guided, pace map-guided, and substrate-based VT ablation strategies to be performed using focal PFA in a manner analogous to conventional focal ablation workflows.

Patients enrolled in the registry will undergo VT ablation according to standard clinical practice and at the discretion of the treating electrophysiologist. Mapping strategies may include activation mapping, voltage mapping, substrate mapping, pace mapping, entrainment mapping, programmed ventricular stimulation, intracardiac imaging, coronary assessment, and integration of pre-procedural imaging when clinically indicated. Adjunctive radiofrequency ablation may be performed if considered clinically necessary and will be systematically documented.

The registry will collect data on patient characteristics, underlying heart disease, left ventricular function, arrhythmia indication, mapping strategy, procedural workflow, Centauri PFA application parameters, use of adjunctive ablation, acute procedural endpoints, and periprocedural complications. Safety outcomes of interest include pericardial effusion or tamponade, vascular complications, coronary spasm or coronary injury, conduction disturbances, ventricular arrhythmia induction, stroke, myocardial infarction, heart failure deterioration, and death.

Follow-up will be performed at approximately 3, 6, and 12 months and will assess VT recurrence, implantable cardioverter-defibrillator therapies, antitachycardia pacing, ICD shocks, arrhythmia-related hospitalization, repeat ablation, antiarrhythmic drug therapy, and survival.

The aim of the PULSE-VT Registry is to generate systematic real-world evidence on the feasibility, procedural characteristics, safety, acute efficacy, and short- to mid-term clinical outcomes of focal VT ablation using the Centauri PFA System.

Patients included in the PULSE-VT Registry undergo clinically indicated catheter ablation of ventricular tachycardia using focal pulsed field ablation with the Centauri™ PFA System. The registry is observational and does not alter clinical decision-making, procedural strategy, or follow-up. Ablation is performed according to standard clinical practice and at the discretion of the treating electrophysiologist. The intervention of interest is focal, point-by-point PFA integrated into established electroanatomical mapping workflows. Mapping may include activation, substrate, pace, or entrainment mapping, programmed stimulation, intracardiac imaging, coronary assessment, and imaging integration when clinically indicated. Adjunctive radiofrequency ablation may be performed if clinically necessary and documented. Data on procedural characteristics, safety, acute efficacy, VT recurrence, ICD therapies, repeat ablation, hospitalization, antiarrhythmic drug use, and survival will be collected.

Plazo: From index ablation with the Centauri™ PFA System procedure to 12 months of follow-up.

Proportion of patients free from recurrent ventricular tachycardia after clinically indicated VT ablation using the Centauri™ PFA System. VT recurrence is defined as documented sustained VT, appropriate ICD therapy including antitachycardia pacing or shock, arrhythmia-related hospitalization, or repeat VT ablation during follow-up.

Plazo: Periprocedural

Proportion of patients experiencing acute procedure-related adverse events during or immediately after clinically indicated VT ablation using the Centauri™ PFA System. Events include pericardial effusion or tamponade, vascular complications, coronary spasm or coronary injury, conduction disturbances, stroke or transient ischemic attack, myocardial infarction, acute heart failure deterioration, sustained hemodynamic instability, procedure-related death, or other clinically relevant complications.

Plazo: During the index ablation procedure; assessed at the end of the procedure.

Proportion of patients achieving acute procedural success after clinically indicated ventricular tachycardia ablation using the Centauri™ PFA System. Acute procedural success is defined as non-inducibility of the targeted clinical VT or relevant sustained monomorphic VT at the end of the procedure, and/or abolition of targeted arrhythmogenic substrate or local abnormal ventricular electrograms according to the predefined procedural strategy.

Multicenter Study on Effectiveness and Safety of Focal Pulsed Field Ablation of Ventricular Tachycardia in Patients With Structural Heart Disease