Ignite Creation Date:
2024-05-06 @ 3:45 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04747353
Status:
COMPLETED
Last Update Posted:
2023-05-01
First Post:
2021-01-26
Brief Title:
Computed Tomography Targets for Efficient Guidance of Catheter Ablation in Ventricular Tachycardia MAP-IN-HEART
Sponsor:
University Hospital Bordeaux
Organization:
University Hospital Bordeaux
Study Overview
Official Title:
Computed Tomography Targets for Efficient Guidance of Catheter Ablation in Ventricular Tachycardia MAP-IN-HEART
Status:
COMPLETED
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MAP-IN-HEART
Brief Summary:
The hypothesis of MAP IN HEART is that catheter ablation for post-infarction ventricular tachycardia VT can be largely improved through a direct definition of primary ablation targets from pre-operative CT scan imaging The objective of is to demonstrate that catheter ablation of post-infarction VT targeting left ventricular wall thickness channels as defined from CT scan is feasible and associated with favorable efficacy efficiency and safety profiles A single-arm prospective cohort study will be conducted including 40 patients over 3 European centres Baseline procedural and 6-month follow-up data will be analyzed
Detailed Description:
Background Although catheter ablation is a recommended therapeutic option in patients with history of myocardial infarction presenting with sustained ventricular tachycardia VT1 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 interventions2 Pre-operative CT scan imaging was shown able to identify arrhythmogenic sites within scar through a detailed analysis of left ventricular LV wall thickness34 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 ie 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
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 ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None