Clinical trial NCT06371729: DEEP Substrate Mapping Versus Activation Mapping for VT
Official title: Substrate-based DEEP Mapping Versus Activation Mapping: A Prospective Randomized Multicenter Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ventricular Tachycardia
Keywords: DEEP substrate mapping
Activation mapping
Lead sponsor: IRCCS Ospedale San Raffaele
Sponsor class: OTHER
First posted: 2024-04-17
Enrollment: 222
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 outcomes:
measure: VT recurrence free survival rate
timeFrame: after 12 months from the procedure
measure: Procedural feasibility
timeFrame: During the index procedure
Secondary outcomes:
measure: Procedural data.
timeFrame: During the index procedure
measure: Hemodynamic VT tolerance
timeFrame: During the index procedure
measure: Clinical follow up data.
timeFrame: after 12 months from the procedure
Other outcomes:
Locations:
city: Milan
country: Italy
facility: San Raffaele Hospital
state: Lombardy
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.