Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06371729

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

Led by IRCCS Ospedale San Raffaele · Updated on 2026-03-27

222

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating two main techniques used for guiding ventricular tachycardia (VT) ablation: substrate-based DEEP mapping and activation mapping. This randomized clinical trial aims to test whether activation mapping is better than DEEP mapping at reducing the return of ventricular tachycardia. The study focuses on comparing the success rates of these methods 12 months after the procedure and their ease of use during the procedure. The study involves two groups: one will receive the substrate-based DEEP mapping approach, which identifies arrhythmogenic areas during normal heart rhythm using specialized catheters, while the other will receive VT activation mapping, which locates reentry circuits to target for ablation. Both groups use similar advanced mapping catheters and ablation devices. The procedure details and effectiveness are assessed during the procedure and followed up over time. Participants will undergo the ablation procedure guided by one of the two mapping methods. Researchers will evaluate outcomes including the recurrence-free survival rate of VT at 12 months and procedural feasibility during the initial procedure. Additional measurements include procedural data, tolerance to VT during the procedure, and clinical follow-up information after 12 months. The total study duration includes initial treatment and at least one year of follow-up to monitor long-term effects.

CONDITIONS

Brief Title

DEEP Substrate Mapping Versus Activation Mapping for VT

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with an implanted ICD (all brands)
  • Patients indicated for ventricular tachycardia ablation (first or redo procedures) supported by EnSite 3D mapping system
  • Diagnosis includes previous myocardial infarction, myocarditis, or arrhythmogenic right/left ventricular dysplasia
  • Age 18 years or older
  • Willing and able to give informed consent and comply with study assessments
Not Eligible

You will not qualify if you...

  • Contraindication to anticoagulants
  • Presence of blood clots (thrombi)
  • Presence of mitral or aortic prosthetic valve
  • Recent myocardial infarction, unstable angina, or coronary artery bypass surgery within 3 months
  • Ventricular tachycardia caused by reversible conditions
  • Life expectancy less than 1 year as judged by the investigator
  • Contraindications to ablation or diagnostic catheters or cardiac catheterization
  • Female participants who are pregnant, breastfeeding, or planning pregnancy during the trial

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 1 day (index procedure)

Participants undergo a catheter-based mapping and ablation procedure using either substrate-based DEEP mapping or VT activation mapping to target ventricular tachycardia.

1 procedure visit (in-person)

Follow-up

Duration - 12 months

Participants are followed for clinical outcomes including VT recurrence and procedural feasibility over a 12-month period after the procedure.

Periodic follow-up visits over 12 months

Trial Site Locations

Total: 1 location

1

San Raffaele Hospital

Milan, Lombardy, Italy, 20132

Actively Recruiting

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Research Team

A

Andrea Radinovic, MD

A

Anna Montagna, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Multicenter Study of Ischemic Ventricular Tachycardia Ablation With Decrement-Evoked Potential (DEEP) Mapping With Extra Stimulus.

Andreu Porta-Sánchez, Nicholas Jackson, Peter Lukac...

https://pubmed.ncbi.nlm.nih.gov/30089555

Decrement Evoked Potential Mapping: Basis of a Mechanistic Strategy for Ventricular Tachycardia Ablation.

Nicholas Jackson, Sigfus Gizurarson, Karthik Viswanathan...

https://pubmed.ncbi.nlm.nih.gov/26480929

Complete Electroanatomic Imaging of the Diastolic Pathway Is Associated With Improved Freedom From Ventricular Tachycardia Recurrence.

Alexios Hadjis, Antonio Frontera, Luca Rosario Limite...

https://pubmed.ncbi.nlm.nih.gov/32755381