DEEP Substrate Mapping Versus Activation Mapping for VT

March 24, 2026 updated by: Dr. Paolo Della Bella, IRCCS Ospedale San Raffaele

Substrate-based DEEP Mapping Versus Activation Mapping: A Prospective Randomized Multicenter Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

222

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • Lombardy
      • Milan, Lombardy, Italy, 20132
        • Recruiting
        • San Raffaele Hospital
        • Contact:
          • Paolo Della Bella, MD
        • Contact:
          • Andrea Radinovic, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: group 1
Substrate-based DEEP Mapping
Procedure: 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)
Experimental: group 2
VT Activation Mapping
Procedure: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VT recurrence free survival rate
Time Frame: 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
after 12 months from the procedure
Procedural feasibility
Time Frame: During the index procedure
Percentage of patients in which the mapping strategy was achievable and reasons for failure.
During the index procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedural data.
Time Frame: During the index procedure
Procedure duration (minutes)
During the index procedure
Hemodynamic VT tolerance
Time Frame: During the index procedure
Hemodynamic decompensation during the procedure. (Arterial blood pressure <80 mmHg)
During the index procedure
Clinical follow up data.
Time Frame: after 12 months from the procedure
  • Number of ICD shocks at follow-up
  • Rate of subsequent hospitalizations for VT recurrence/HF
  • Cardiac mortality.
after 12 months from the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Ospedale San Raffaele

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 13, 2024

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

April 10, 2024

First Submitted That Met QC Criteria

April 16, 2024

First Posted (Actual)

April 17, 2024

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 24, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DEEP-VT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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