DEEP Substrate Mapping Versus Activation Mapping for VT

NCT06371729 | Recruiting

• 1 other identifier: DEEP-VT
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ventricular Tachycardia

Keywords

DEEP substrate mapping; Activation mapping

Outcome Measures

Primary Outcomes (2)

• VT recurrence free survival rate

  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

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

  During the index procedure

Secondary Outcomes (3)

• Procedural data.

  During the index procedure

• Hemodynamic VT tolerance

  During the index procedure

• Clinical follow up data.

  after 12 months from the procedure

Study Arms (2)

group 1

EXPERIMENTAL

Substrate-based DEEP Mapping

Procedure: DEEP mapping

group 2

EXPERIMENTAL

VT Activation Mapping

Procedure: Activation Mapping

Interventions

DEEP mapping PROCEDURE

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)

group 1

Activation Mapping PROCEDURE

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)

group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS Ospedale San Raffaele: lead

Study Sites (1)

San Raffaele Hospital

Milan, Lombardy, 20132, Italy

RECRUITING

Related Publications (3)

• 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.

  PMID: 30089555 BACKGROUND

• 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.

  PMID: 26480929 BACKGROUND

• 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.

  PMID: 32755381 BACKGROUND

MeSH Terms

Conditions

Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Andrea Radinovic, MD

CONTACT

+390226436316; radinovic.andrea@hsr.it

Anna Montagna, PhD

CONTACT

+390226437489; montagna.anna@hsr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: April 10, 2024
• First Posted: April 17, 2024
• Study Start: June 13, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)