An observational study in Ventricular Tachycardia (VT), Structural Heart Disease and Ischemic Cardiomyopathy, sponsored by Sana Hanse Hospital Wismar. Enrolling by invitation at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Sana Hanse Hospital Wismar · Observational
The PULSE-VT Registry is a combined retrospective and prospective, multi-centre, observational registry designed to evaluate the safety and efficacy of focal pulsed-field ablation (fPFA) using the Centauri™ generator for catheter ablation of ventricular tachycardia (VT). The registry captures detailed procedural, clinical, and follow-up data across participating electrophysiology centres performing VT ablation with this ablation energy modality.
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.
451 studies on the registry are indexed under Tachycardia, Ventricular; 120 are open to participants now.
This study's planned enrollment of 100 is below the median of 167 across 147 observational studies indexed under Tachycardia, Ventricular.
Browse Tachycardia, Ventricular studies →This is the only study on the registry with Sana Hanse Hospital Wismar as lead sponsor.
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The study population consists of consecutive adult patients treated at participating centers who undergo clinically indicated catheter ablation for sustained ventricular tachycardia or recurrent ventricular arrhythmias using focal pulsed field ablation with the Centauri™ PFA System. Patients may have ischemic or non-ischemic structural heart disease, reduced or preserved left ventricular function, prior ICD therapies, electrical storm, recurrent VT, or drug-refractory ventricular arrhythmias. The decision to perform VT ablation and the procedural strategy are based solely on standard clinical care and the discretion of the treating electrophysiologist. Patients may be included retrospectively or prospectively if relevant procedural and follow-up data are available.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Clinical indication for VT ablation including one or more of the following:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Freedom From Ventricular Tachycardia Recurrence After Focal PFA VT Ablation
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.
Time frame: From index ablation with the Centauri™ PFA System procedure to 12 months of follow-up.
Incidence of Acute Procedure-Related Adverse Events
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.
Time frame: Periprocedural
Acute Procedural Success of Focal PFA VT Ablation
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.
Time frame: During the index ablation procedure; assessed at the end of the procedure.
Plan to share: Undecided
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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