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DEEP Substrate Mapping Versus Activation Mapping for VT

ConditionVentricular Tachycardia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIRCCS Ospedale San Raffaele

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • DEEP mapping

    Procedure/Surgery

    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

    Procedure/Surgery

    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)

Treatment groups

222 Participants
are divided into 2 treatment groups
Group A: group 1Experimental treatment 1 intervention
Group B: group 2Experimental treatment 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

IRCCS Ospedale San Raffaele

Lead sponsor

Source ClinicalTrials.gov
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