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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group 1 | Experimental | Substrate-based DEEP Mapping |
|
| group 2 | Experimental | VT Activation Mapping |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural data. | Procedure duration (minutes) | During the index procedure |
| Hemodynamic VT tolerance | Hemodynamic decompensation during the procedure. (Arterial blood pressure <80 mmHg) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrea Radinovic, MD | Contact | +390226436316 | radinovic.andrea@hsr.it | |
| Anna Montagna, PhD | Contact | +390226437489 | montagna.anna@hsr.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Raffaele Hospital | Recruiting | Milan | Lombardy | 20132 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30089555 | Background | 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. | |
| 26480929 |
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| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
| 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) |
|
| During the index procedure |
| Clinical follow up data. |
| after 12 months from the procedure |
| 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. |
| 32755381 | 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. |
| D000075224 |
| Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |