Substrate-based DEEP Mapping Versus Activation Mapping. A Prospective Randomized Multicenter Study.

Ventricular Tachycardia Clinical Trial

Official title:

Substrate-based DEEP Mapping Versus Activation Mapping: A Prospective Randomized Multicenter Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06371729
• Other study ID #: DEEP-VT
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: July 2027

Study information

• Verified date: April 2024
• Source: IRCCS Ospedale San Raffaele
• Contact: Andrea Radinovic, MD
• Phone: +390226436316
• Email: radinovic.andrea[@]hsr.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Substrate-based DEEP mapping and activation mapping are the two main techniques used for ventricular tachycardia (VT) ablation. There is no sufficiently reliable data in the medical scientific literature comparing the extent of applicability, the results of the procedure strategy, 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 outcome of the study is to compare the efficacy as a recurrence-free survival rate of ventricular tachycardia, at 6 and 12 months, of substrate-based DEEP mapping versus activation mapping in guiding catheter ablation to prevent VT recurrence.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 222
• Est. completion date: July 2027
• Est. primary completion date: July 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with an implanted ICD (all brands)
• Patients with the indication of Ventricular Tachycardia Ablation procedure, supported by EnSite 3D mapping system, for the following disease aetiologies: previous MI, myocarditis, arrhythmogenic right/left ventricular dysplasia
• Patient that underwent a previous VT catheter ablation
• 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 or Aortic prosthetic valve.
• Recent (<3 months) myocardial infarction, unstable angina, or Coronary Artery Bypass.
• Ventricular Tachycardia caused by reversible pathology.
• Life expectancy < 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.

Related Conditions & MeSH terms

• Tachycardia
• Tachycardia, Ventricular
• Ventricular Tachycardia

Intervention

Procedure:
• DEEP 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 (1). 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
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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Ospedale San Raffaele

References & Publications (3)

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 — View 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 Tachycard — View 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) — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare the efficacy of substrate-based DEEP mapping versus Activation mapping in guiding catheter ablation to prevent VT recurrences	The primary endpoint of this study is the rate of ventricular tachycardia recurrence within 12 months of catheter ablation in ICD patients undergoing the substrate-based DEEP mapping procedure compared to ICD patients undergoing the Activation mapping procedure	6 and 12 months