ClinicalTrials.gg
RecruitingNCT06371729Updated Mar 27, 2026

DEEP Substrate Mapping Versus Activation Mapping for VT

An interventional study of DEEP mapping and Activation Mapping in Ventricular Tachycardia, sponsored by IRCCS Ospedale San Raffaele. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-27.

Sponsored by IRCCS Ospedale San Raffaele · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2024; still recruiting 2 years 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
222
Allocation
Randomized
Ages
18 Years and older
Sex
All
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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.

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Conditions studied

  • Ventricular Tachycardia

Keywords

  • DEEP substrate mapping
  • Activation mapping
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In context

Tachycardia, Ventricular

451 studies on the registry are indexed under Tachycardia, Ventricular; 120 are open to participants now.

This study's planned enrollment of 222 is above the median of 71 across 280 interventional studies indexed under Tachycardia, Ventricular.

Browse Tachycardia, Ventricular studies →

Lead sponsor

IRCCS Ospedale San Raffaele is the lead sponsor of 36 studies on the registry; 28 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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.

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 for participation in the trial and is available to respect the assessments described in the protocol and informed consent form.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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.
Terms in these criteria, in plain language(3)

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.

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.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

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.

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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
222 participants (estimated)

Study arms

  • Experimental
    group 1

    Substrate-based DEEP Mapping

    Procedure: DEEP mapping

  • Experimental
    group 2

    VT Activation Mapping

    Procedure: Activation Mapping

Interventions

  • ProcedureDEEP 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)

  • ProcedureActivation 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)

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What researchers measure

Primary outcomes

  1. VT recurrence free survival rate

    Compare the efficacy of substrate-based DEEP mapping versus Activation mapping in guiding catheter ablation to prevent VT recurrences

    Time frame: after 12 months from the procedure

  2. Procedural feasibility

    Percentage of patients in which the mapping strategy was achievable and reasons for failure.

    Time frame: During the index procedure

Secondary outcomes

  1. Procedural data.

    Procedure duration (minutes)

    Time frame: During the index procedure

  2. Hemodynamic VT tolerance

    Hemodynamic decompensation during the procedure. (Arterial blood pressure \<80 mmHg)

    Time frame: During the index procedure

  3. Clinical follow up data.

    * Number of ICD shocks at follow-up * Rate of subsequent hospitalizations for VT recurrence/HF * Cardiac mortality.

    Time frame: after 12 months from the procedure

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Study locations

1 of 1 sites recruiting
  • San Raffaele Hospital
    Milan, Lombardy 20132, Italy
    Recruiting
    • Paolo Della Bella, MD · Contact
    • Andrea Radinovic, MD · Contact
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References and documents

Publications

  • Porta-Sanchez A, Jackson N, Lukac P, Kristiansen SB, Nielsen JM, Gizurarson S, Masse S, Labos C, Viswanathan K, King B, Ha ACT, Downar E, Nanthakumar K. Multicenter Study of Ischemic Ventricular Tachycardia Ablation With Decrement-Evoked Potential (DEEP) Mapping With Extra Stimulus. JACC Clin Electrophysiol. 2018 Mar;4(3):307-315. doi: 10.1016/j.jacep.2017.12.005. Epub 2018 Feb 3. PubMed 30089555 ↗
  • Jackson N, Gizurarson S, Viswanathan K, King B, Masse S, Kusha M, Porta-Sanchez A, Jacob JR, Khan F, Das M, Ha AC, Pashaei A, Vigmond E, Downar E, Nanthakumar K. Decrement Evoked Potential Mapping: Basis of a Mechanistic Strategy for Ventricular Tachycardia Ablation. Circ Arrhythm Electrophysiol. 2015 Dec;8(6):1433-42. doi: 10.1161/CIRCEP.115.003083. Epub 2015 Oct 19. PubMed 26480929 ↗
  • Hadjis A, Frontera A, Limite LR, Bisceglia C, Bognoni L, Foppoli L, Lipartiti F, Paglino G, Radinovic A, Tsitsinakis G, Calore F, Della Bella P. Complete Electroanatomic Imaging of the Diastolic Pathway Is Associated With Improved Freedom From Ventricular Tachycardia Recurrence. Circ Arrhythm Electrophysiol. 2020 Sep;13(9):e008651. doi: 10.1161/CIRCEP.120.008651. Epub 2020 Jul 28. PubMed 32755381 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06371729
Lead sponsor
IRCCS Ospedale San Raffaele
Responsible party
Dr. Paolo Della Bella (Medical Doctor, IRCCS Ospedale San Raffaele) — Principal investigator
First posted
Apr 17, 2024
Start date
Jun 13, 2024
Primary completion
Jun 2027 (estimated)
Completion
Jun 2027 (estimated)
Last update
Mar 27, 2026

Study contacts

Andrea Radinovic, MD
Contact
radinovic.andrea@hsr.it
+390226436316
Anna Montagna, PhD
Contact
montagna.anna@hsr.it
+390226437489

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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