Comparing two mapping techniques for treating ventricular tachycardia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to compare two mapping techniques, DEEP substrate mapping and activation mapping, for guiding ablation procedures in patients with ventricular tachycardia (VT). The study will randomly assign participants to receive one of the two mapping strategies to determine which is more effective in reducing the recurrence of VT. The primary endpoint is to evaluate the recurrence-free survival rate at 12 months post-procedure, along with assessing the feasibility of each mapping approach. By directly comparing these techniques, the trial seeks to provide insights into the best practices for VT ablation.

Why it matters

Who can join: the full rules

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.

Where it's running

• San Raffaele Hospital
  Milan, Lombardy, Italy Recruiting

Study contacts

• Study coordinator: Andrea Radinovic, MD
• Email: radinovic.andrea@hsr.it
• Phone: +390226436316

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.