Ventricular Tachycardia Ablation and Myocardial Scar Characterization With Magnetic Resonance

NCT04694079 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2025-12-15

No results posted yet for this study

Summary

Previous monocentric experiences have already highlighted the role of preoperative cardiac imaging, in particular of cardiac magnetic resonance (CMR) and tomography (CT), in improving the ablation results of scar-related ventricular tachycardia (VT). A better characterization of scar obtained with high quality CMR images and post processing data with creation of maps exploring the heart in concentric layers from the endocardium to the epicardium could allow a personalized and more precise approach to this pathology.

Aim of the study - Evaluating the feasibility and possible benefit of CMR-guided ablative approach (group 1: ablation of the "anatomical" channels of heterogeneous tissue within the scar) compared to CMR-aided approach (group 2: ablation of the "electrical" conduction channels within the scar) and standard approach (group 3: ablation guided by an electro-anatomical system without the aid of CMR) in a multi-center Tuscan study.

What would add the project to what is known - The achievement of the objectives by the project would allow to propose a personalized ablation on the basis of the scar characterization and would allow a better efficacy, efficiency of the procedure and probably also a safer treatment

Conditions

  • Ventricular Tachycardia
  • Myocardial Fibrosis

Interventions

PROCEDURE

Group 1, CMR-guided/aided VT ablation

Ablation of the "anatomical" channels of heterogeneous tissue within the scar

PROCEDURE

Group 2, CMR-aided VT ablation

Ablation of the "electrical" conduction channels within the scar

PROCEDURE

Group 3, Electroanatomical guided ablation

Ablation guided by an electro-anatomical system without the aid of CMR

Sponsors & Collaborators

  • Azienda USL Toscana Nord Ovest

    collaborator OTHER
  • Azienda USL Toscana Sud Est

    collaborator OTHER_GOV
  • Azienda Ospedaliera Universitaria Senese

    collaborator OTHER
  • Fondazione Toscana Gabriele Monasterio

    collaborator OTHER
  • Centro Medico Teknon

    collaborator OTHER
  • Azienda Ospedaliero, Universitaria Pisana

    lead OTHER

Principal Investigators

  • GIULIO ZUCCHELLI, MD, PhD · Azienda Ospedaliero, Universitaria Pisana

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-03
Primary Completion
2025-07-17
Completion
2025-07-17

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04694079 on ClinicalTrials.gov