Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Ventricular Tachycardia
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Catheter ablation procedure performed as part of standard care, although with the addition of an image-based 3D heart model including detailed anatomy and primary ablation targetsMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 90 years
Gender
Both males and females

Description

Background: Although catheter ablation is a recommended therapeutic option in patients with history of myocardial infarction presenting with sustained ventricular tachycardia (VT),1 the current approach relies on lengthy, poorly reproducible and poorly standardized identification of targets derived ...

Background: Although catheter ablation is a recommended therapeutic option in patients with history of myocardial infarction presenting with sustained ventricular tachycardia (VT),1 the current approach relies on lengthy, poorly reproducible and poorly standardized identification of targets derived from invasive catheter measurements. As a consequence, the rate of VT recurrence remains high, leading to repeat interventions.2 Pre-operative CT scan imaging was shown able to identify arrhythmogenic sites within scar through a detailed analysis of left ventricular (LV) wall thickness.3,4 This study aims at demonstrating that using these as primary targets for ablation is a feasible strategy associated with favorable efficacy, efficiency and safety profiles. Methods: 40 patients with post-infarction VT referred for catheter ablation will be included over 3 European centres. Pre-operative CT scan will be processed to obtain a 3D model of the patient heart comprising detailed anatomy and LV wall thickness maps. Channels of relatively preserved thickness penetrating within severely thinned scar (i.e. CT-channels) will be identified using a proprietary algorithm developed at the IHU LIRYC, University of Bordeaux, and used as primary targets for catheter ablation. During the intervention, the 3D model along with pre-operatively defined targets will be registered in the 3D mapping space, and each CT-channel will be transected by ablation. The inducibility of VT will then be tested and any VT remaining inducible after CT-channels ablation will be targeted using conventional catheter mapping techniques, with a composite procedural endpoint combining the ablation of all CT channels and the non-inducibility of any VT. Procedural and 6-month follow-up data will be analyzed to assess the feasibility of the approach and report its efficiency, efficacy and safety profiles. Expected results: the CT-guided ablation strategy is expected to be feasible in a vast majority of post-infarction patients referred for VT ablation, and to be extremely time-efficient, the lengthy diagnostic part of the procedure (catheter mapping) being moved pre-operatively (imaging). The short procedure duration should translate into a favorable safety profile. The strategy should also be associated with a high efficacy in eliminating the arrhythmia, thanks to a more comprehensive definition of targets and to the dedication of the procedure time almost entirely to therapy. In conclusion, the present study should provide solid proof of concept on which randomized controlled trials may be built.

Tracking Information

NCT #
NCT04747353
Collaborators
European Commission (ERC, H2020)
Investigators
Not Provided