RecruitingNot ApplicableNCT06669299

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

The Value of Late Non-Invasive Programmed Stimulation (NIPS) in the Setting of Ventricular Tachycardia (VT) Ablation to Guide the Subsequent VT Therapeutic Strategies: a Prospective Randomized Multicenter Study

Sponsor

IRCCS Ospedale San Raffaele

Enrollment

51 participants

Start Date

Jun 12, 2025

Study Type

INTERVENTIONAL

Conditions

Ventricular Tachycardia (VT)

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

Min Age: 18 Years

Inclusion Criteria5

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 Criteria8

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

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Interventions

PROCEDURERe-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.

DRUGAntiarrhythmic 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.