Ventricular Tachycardia
Conditions
Keywords
DEEP substrate mapping, Activation mapping
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.
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)
Sponsors
IRCCS Ospedale San Raffaele
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VT recurrence free survival rate | 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 |
| Procedural feasibility | During the index procedure | Percentage of patients in which the mapping strategy was achievable and reasons for failure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedural data. | During the index procedure | Procedure duration (minutes) |
| Hemodynamic VT tolerance | During the index procedure | Hemodynamic decompensation during the procedure. (Arterial blood pressure \<80 mmHg) |
| Clinical follow up data. | after 12 months from the procedure | * Number of ICD shocks at follow-up * Rate of subsequent hospitalizations for VT recurrence/HF * Cardiac mortality. |
Countries
Italy
Contacts
CONTACTAndrea Radinovic, MD
CONTACTAnna Montagna, PhD
Outcome results
None listed