Clinical trial NCT02275104: Multimodal Image Processing Software to Guide Cardiac Ablation Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventricular Arrhythmias
Persistent Atrial Fibrillation
Keywords: Ventricular arrhythmias
Persistent atrial fibrillation
Ablation guidance
Software
MRI (Magnetic resonance imaging)
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2014-10-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with ventricular arrhythmias or persistent atrial fibrillation

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

Detailed description: Cardiac electrical disorders are a major cause of human mortality and morbidity worldwide. Catheter ablation therapy has become part of international recommendations for the management of both atrial and ventricular arrhythmias. Advanced catheter localization systems now enable 3-dimensional mapping of cardiac electrical activity. The integration of 3-dimensional imaging data acquired prior to the procedure and its merging with the mapping geometry was shown feasible. Available non-invasive imaging modalities can provide critical complementary information to assist cardiac mapping and ablation. Multidetector computed tomography can provide valuable information on patient's anatomy (cardiac chambers, pulmonary veins, coronary arteries and veins, phrenic nerve or oesophagus location, epicardial fat thickness). Magnetic resonance imaging and positron emission tomography can provide valuable information on myocardial substrate (scar location), because most arrhythmias occur on structurally diseased hearts. In addition, a body surface mapping technology was recently developed, enabling non-invasive real-time whole-heart 3-dimensional electrophysiological mapping. The system computes unipolar epicardial electrograms from an array of body surface potentials acquired with a multi-electrode vest. Because of its real-time and whole-heart nature, body surface mapping gives access to the assessment of previously non-mappable arrhythmias such as cardiac fibrillation and non-sustained or poorly tolerated arrhythmias. This technology might be of value to preemptively identify ablation targets form epicardial activation (earliest epicardial exit of the circuit in cardiac reentrant tachycardias, location of rotor cores in cardiac fibrillation).

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years old
* Body weight \< 140 kg
* Indicated ablation for ventricular tachycardia or persistent atrial fibrillation

Exclusion Criteria:

* Severe renal insufficiency defined by creatinine clearance \< 30 mL/min

Primary outcomes:
measure: To build MIGAT software
timeFrame: 28 months
measure: To test MIGAT for real-time guidance during cardiac ablation procedures.
timeFrame: 28 months
Secondary outcomes:
measure: To improve the compatibility of MIGAT with daily clinical use
timeFrame: 28 months
measure: Correlations between MIGAT predictions from non-invasive data, and ablation targets observed during invasive procedures
timeFrame: 28 months
Other outcomes:
Locations:
city: Pessac
country: France
facility: Hôpital cardiologique du Haut-Lévêque
Study officials:
References: