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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
San Raffaele Hospital
RECRUITING
Milan
Contact Information
Primary
Andrea Radinovic, MD
radinovic.andrea@hsr.it
+390226436316
Backup
Anna Montagna, PhD
montagna.anna@hsr.it
+390226437489
Time Frame
Start Date: 2024-06-13
Estimated Completion Date: 2027-06
Participants
Target number of participants: 222
Treatments
Experimental: group 1
Substrate-based DEEP Mapping
Experimental: group 2
VT Activation Mapping
Related Therapeutic Areas
Sponsors
Leads: IRCCS Ospedale San Raffaele

This content was sourced from clinicaltrials.gov