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Clinical Trials in Italy / NCT06371729
Recruiting Not applicable

DEEP Substrate Mapping Versus Activation Mapping for VT

NCT06371729 · tracked via the Priya Life Science Italy tracker
Sponsor
IRCCS Ospedale San Raffaele
Phase
Not applicable
Started
2024-06-13
Last updated
2026-03-27

Condition(s) studied

Ventricular Tachycardia

Investigational drug(s) / intervention(s)

DEEP mappingActivation Mapping

DEEP mapping: The Substrate-based DEEP Mapping aims to identify the arrhythmogenic substrate of VT in sinus rhythm (SR). A standardized VT mapping and ablation procedure in SR has been proven effective in reducing VT recurrences in a multicenter setting by targeting late potential (LP) abolition. Regions with LPs and LAVAs that displayed decremental behavior evoked during right ventricular (RV) pacing with extra stimuli (decrement-evoked potential; DEEP), colocalized with the regions of the initiation and diastolic pathway of the VT more accurately than those areas displaying non decremental LPs. Device use for mapping and ablation procedure: FlexAbility/Tactiflex/TactiCath Ablation Catheter Sensor Enabled (Abbott, MN), high-density grid mapping catheter (GMC; Advisor HD Grid Mapping Catheter Sensor Enabled, Abbott, MN)

Activation Mapping: VT Activation Mapping can localize reentry circuits, and the diastolic pathway isthmus is the desirable target for ablation when possible because it can eliminate the elements required for reentry. In fact, activation mapping of the entire diastolic pathway is associated with higher freedom from VT recurrences compared to substrate modification Device use for mapping and ablation procedure: FlexAbility/Tactiflex/TactiCath Ablation Catheter Sensor Enabled (Abbott, MN), high-density grid mapping catheter (GMC; Advisor HD Grid Mapping Catheter Sensor Enabled, Abbott, MN)

Study summary

Substrate-based DEEP mapping and activation mapping are two of the main techniques used for guiding ventricular tachycardia (VT) ablation. There is no data comparing directly the extent of applicability, procedural results, and the long-term outcomes between the two mapping strategies.This randomized clinical trial aims to test whether activation mapping is superior to DEEP mapping to reduce ventricular tachycardia recurrence.

The primary endpoint of the study is to compare recurrence-free survival rate of ventricular tachycardia at 12 months and procedural feasibility of substrate-based DEEP mapping versus activation mapping for VT ablation.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patients with an implanted ICD (all brands) * Patients with the indication for Ventricular Tachycardia Ablation (both first and redo procedures), supported by EnSite 3D mapping system, for the following disease aetiologies: previous MI, myocarditis, arrhythmogenic right/left ventricular dysplasia * Age: 18 years or more. * A participant is willing and able to give informed consent for participation in the trial and is available to respect the assessments described in the protocol and informed consent form. Exclusion Criteria: * Contraindication to anticoagulants. * Presence of thrombi. * Presence of Mitral and Aortic prosthetic valve. * Recent (less than 3 months) myocardial infarction, unstable angina, or Coronary Artery Bypass. * Ventricular Tachycardia caused by reversible pathology. * Life expectancy less than 1 year, according to the investigator. * Contraindications to the use of ablation/diagnostic catheters or to cardiac catheterization. * Female participant who is pregnant, lactating, or planning pregnancy during the course of the trial.

Primary outcome measure(s)

  • VT recurrence free survival rate — after 12 months from the procedure
    Compare the efficacy of substrate-based DEEP mapping versus Activation mapping in guiding catheter ablation to prevent VT recurrences
  • Procedural feasibility — During the index procedure
    Percentage of patients in which the mapping strategy was achievable and reasons for failure.

Trial sites (1)

FacilityCityRegionStatus
San Raffaele Hospital Milan Lombardy Recruiting

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Other trials for the same condition

In-hospital Stellate Ganglion Block for Arrhythmic Storm Recruiting
Personalized Therapy Study - Intrinsic Antitachycardia Pacing Post-Approval Study (iATP PAS) Active, not recruiting
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 NCT06371729 on ClinicalTrials.gov ↗ ← All trials in Italy