Ventricular Tachycardia Ablation and Myocardial Scar Characterization With Magnetic Resonance
NCT04694079 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 104
Last updated 2025-12-15
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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