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Clinical Trials in Italy / NCT06669299
Recruiting Not applicable

Non-Invasive Programmed Stimulation (NIPS) to Guide the Subsequent VT Therapeutic Strategies

NCT06669299 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2025-06-12
Last updated
2026-03-27

Condition(s) studied

Ventricular Tachycardia (VT)

Investigational drug(s) / intervention(s)

Re-Do ventricular tachycardia ablationAntiarrhythmic Drug Therapy (amiodarone, sotalol, or mexiletine) →

Re-Do ventricular tachycardia ablation: 1\. Programmed ventricular stimulation (PVS); 2. Mapping during Sinus Rhythm (SR) or right ventricular pacing in pacing dependent patients; 3. Late Potentials identification; 4. VT(s) induction with diastolic pathway mapping when possible; 5. Catheter Ablation in SR or, at the operator's discretion, in VT if tolerated by the patient; 6. If VT is not inducible or the diastolic pathway is not mappable, a substrate ablation approach will be performed. 7. PVS is repeatedly attempting to reinduce VT after completing; 8. Endpoint: non-inducibility of any VT.

Antiarrhythmic Drug Therapy (amiodarone, sotalol, or mexiletine): The patients with a positive NIPS already on antiarrhythmic drugs (AAD) before the index procedure will re-start the original antiarrhythmic therapy. Patients who were not on AAD will start a new drug at the operator's discretion (amiodarone, sotalol, or mexiletine) according to clinical practice.

Study summary

The aim of this study is to define the importance of non-invasive programmed stimulation (NIPS) in risk stratification of ventricular tachycardia (VT) recurrence after catheter ablation and to determine the optimal treatment strategy. The primary objective is to establish whether a new VT ablation based on NIPS inducibility will reduce the risk of VT recurrence compared to antiarrhythmic drug therapy.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patients with an implanted ICD (all brands) * Patients who underwent a successful (non-inducibility of any VT) Ventricular Tachycardia Ablation procedure, the "index procedure", supported by EnSite Precision or CARTO 3D mapping systems for the following etiologies: previous MI, myocarditis, ARVD, IDCM. * Induction of monomorphic VT at NIPS 3-7days after a successful index procedure * Age 18 years or more * Able to provide an informed consent to participate to the study and available to respect the assessments described in the protocol. Exclusion Criteria: * Inducible VT after index procedure * Contraindication to anticoagulants * Presence of thrombi * Presence of Mitral and Aortic prosthetic valve * Recent (\<3 months) myocardial infarction or unstable angina or Coronary Artery Bypass * Pregnant or nursing * Ventricular Tachycardia caused by reversible pathology * \< 1 Year life expectancy according to the investigator

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
San Raffaele Hospital, Arrhythmology and Electrophysiology unit Milan Italy Recruiting

More IRCCS Ospedale San Raffaele trials in Italy

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06669299 on ClinicalTrials.gov ↗ ← All trials in Italy