DEEP Substrate Mapping Versus Activation Mapping for VT

Launched by IRCCS OSPEDALE SAN RAFFAELE · Apr 16, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating two different techniques used to treat a heart condition called ventricular tachycardia (VT), which can cause the heart to beat too fast. The two methods being compared are called DEEP mapping and activation mapping. Researchers want to find out if one method is better than the other at preventing VT from coming back after treatment. The main goal is to see which technique leads to fewer patients experiencing a return of VT within a year after their procedure.

To participate in this trial, you need to be at least 18 years old and have an implanted device called an ICD (a type of heart monitor and defibrillator) due to a history of heart issues like a previous heart attack. You also need to be willing to give consent to join the study and follow the trial requirements. Participants will undergo a procedure that may involve one of the mapping techniques to help guide their treatment for VT. It's important to know that certain health conditions may prevent someone from joining, like recent heart issues or being pregnant. If you're interested or think you might qualify, it could be a good idea to discuss this trial with your healthcare provider.

Gender

ALL

Eligibility criteria

• 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.