Multimodal Image Processing Software to Guide Cardiac Ablation Therapy
MIGAT
1 other identifier
observational
100
1 country
1
Brief Summary
MIGAT will develop and transfer software tools to assist ablation therapy of cardiac arrhythmias. The scientific background and objectives of MIGAT differ between atrial and ventricular arrhythmias, because the knowledge on structure-function relationships and the definition of ablation targets are different. Hypothesis: The combination of body surface mapping and imaging will enable a comprehensive non-invasive assessment of cardiac arrhythmia mechanisms and localization, myocardial structural substrate, and cardiac anatomy, all of which should be of value to better define targets for ablation therapy. No software solution is currently available for multimodal data processing, fusion, and integration in 3-dimensional mapping systems to assist ablation. Because such a development requires a trans-disciplinary approach (cardiac electrophysiology, imaging, computer sciences), it is likely to emerge from an academic initiative. Objectives: MIGAT will gather resources from the Liryc Institute (L'Institut de Rythmologie et Modélisation Cardiaque), the Inria (Institut National de Recherche en Informatique et en Automatique) and the University Hospital of Bordeaux to develop a computer-based solution with high expected impact on the daily management of cardiac electrical disorders. The research program will benefit from the MUSIC (Magnetom Avanto, Siemens, Erlangen, Germany) equipment recently funded as part of the "Investissement d'Avenir" program, and combining state-of-the-art electrophysiology and magnetic resonance imaging technology. MIGAT will involve software engineers, computer science researchers, cardiologists, radiologists and clinical research personnel with the following objectives:
- Development of a multimodal data processing software to assist cardiac ablation
- Optimization and Validation of the software in terms of user experience
- Optimization and Validation of the software in terms of clinical performance
- Optimization of software quality compatible with subsequent device certification and randomized-controlled evaluation
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 7, 2014
CompletedFirst Posted
Study publicly available on registry
October 27, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 21, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 21, 2016
CompletedFebruary 17, 2017
February 1, 2017
1.9 years
October 7, 2014
February 16, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
To build MIGAT software
It consists in integrating currently available research prototypes in MedInria software framework. Currently available functionalities will be translated into software specification, and implemented to build MIGAT software.
28 months
To test MIGAT for real-time guidance during cardiac ablation procedures.
To get feedback from clinical data in terms of user experience and accuracy of non-invasive predictions. Radiologists and cardiologists will acquire, process and integrate non-invasive data during 100 cardiac ablation procedures.
28 months
Secondary Outcomes (2)
To improve the compatibility of MIGAT with daily clinical use
28 months
Correlations between MIGAT predictions from non-invasive data, and ablation targets observed during invasive procedures
28 months
Study Arms (2)
Ventricular arrhythmias
Persistent atrial fibrillation
Interventions
Depending on potential contra-indications to iodine-enhanced computed tomography. It will be performed using the usual method on a 64-slice dual energy scanner. Data will be acquired after the injection of 120 mL iodine contrast media. Contrast will be injected at the rate of 4 mL/s without additional saline flush in order to obtain homogeneous enhancement of the 4 cardiac chambers, there by simplifying subsequent segmentation. The objective will be to obtain a 3-dimensional imaging of cardiac structures
Depending on potential contra-indications to gadolinium-enhanced magnetic resonance. It will be performed on the 1.5 Tesla clinical device associated to MUSIC equipment (Magnetom Avanto, Siemens, Erlangen, Germany). Myocardial fibrosis will be imaged using a free-breathing delayed-enhancement method initially developed for atrial imaging. The method uses a 3-dimensional, inversion recovery-prepared, ECG-gated and respiratory-navigated Turbo Fast Low Angle Shot sequence with fat saturation. Acquisition will be initiated 15 minutes after the injection of a double-dose of gadolinium-based contrast media.
Only in patients with a contra-indication to magnetic resonance imaging. It will be performed on a PET/CT 600 device. Acquisition will be preceded by a standard metabolic preparation for 18 fluoro-deoxy-glucose viability imaging. The objective will be to obtain a 3-dimensional imaging of ventricular scar.
It will be obtained using a 252-electrode vest. The position of each electrode with respect to epicardium will be assessed at multi-detector computed tomography prior to mapping. In patients referred for ventricular arrhythmia, body surface mapping will aim at recording the clinical arrhythmia whenever possible. In patients referred for atrial arrhythmia, body surface mapping will aim at recording atrial fibrillation.
Ventricular procedures will be performed endocardially using trans-septal or retro-aortic approach, potentially combined with sub-xiphoid epicardial access. Atrial procedures will be performed endocardially using trans-septal approach to access the left atrium. Bi-atrial bipolar contact mapping will be performed at high density during atrial fibrillation prior to ablation.
Eligibility Criteria
Patients with ventricular arrhythmias or persistent atrial fibrillation
You may qualify if:
- Age \> 18 years old
- Body weight \< 140 kg
- Indicated ablation for ventricular tachycardia or persistent atrial fibrillation
You may not qualify if:
- Severe renal insufficiency defined by creatinine clearance \< 30 mL/min
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital cardiologique du Haut-Lévêque
Pessac, 33604, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 7, 2014
First Posted
October 27, 2014
Study Start
September 1, 2014
Primary Completion
July 21, 2016
Study Completion
July 21, 2016
Last Updated
February 17, 2017
Record last verified: 2017-02