Ventricular ArrhythmiasMIGATNCT02275104
Multimodal Image Processing Software to Guide Cardiac Ablation Therapy
An observational study of Ventricular Arrhythmias and Persistent Atrial Fibrillation, run by University Hospital, Bordeaux at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Arrhythmias, Persistent Atrial Fibrillation
- What is being tested?
- Contrast-enhanced ECG-gated multi-detector computed tomography, Magnetic resonance imaging and Positron emission tomography
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2014to 21 Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with ventricular arrhythmias or persistent atrial fibrillation
Who may be able to join
- Age > 18 years old
- Body weight < 140 kg
- Indicated ablation for ventricular tachycardia or persistent atrial fibrillation
Who cannot join
- Severe renal insufficiency defined by creatinine clearance < 30 mL/min
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
Read the 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).
- Being tested
- Contrast-enhanced ECG-gated multi-detector computed tomography, Magnetic resonance imaging, Positron emission tomography, Body surface mapping, Cardiac ablation procedure
- Keywords
- Ventricular arrhythmias, Persistent atrial fibrillation, Ablation guidance, Software, MRI (Magnetic resonance imaging)
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrast-enhanced ECG-gated multi-detector computed tomographyDevice
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
Magnetic resonance imagingDevice
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.
Positron emission tomographyDevice
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.
Body surface mappingDevice
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.
Cardiac ablation procedureProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Ventricular arrhythmias | Not described Receives: Device: Contrast-enhanced ECG-gated multi-detector computed tomography; Device: Magnetic resonance imaging; Device: Positron emission tomography; Device: Body surface mapping; Procedure: Cardiac ablation procedure | |
| Persistent atrial fibrillation | Not described Receives: Device: Magnetic resonance imaging; Device: Body surface mapping; Procedure: Cardiac ablation procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 28 months
Secondary outcomes (2)
To improve the compatibility of MIGAT with daily clinical use
Radiologists and cardiologists will produce data on their comfort of use (simplicity and rapidity of data preparation before procedures, clarity of procedural displays). An Onsite Software Engineer will be located in the Liryc Institute and will perform the verification and validation tasks, following each procedure with the clinicians in the hospital. He will translate clinical needs into software specification.
Measured: 28 months
Correlations between MIGAT predictions from non-invasive data, and ablation targets observed during invasive procedures
Measured: 28 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2014 (estimated)
- Study start1 Sep 2014
- Primary completion21 Jul 2016
- Study completion21 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular ArrhythmiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02275104
- Sponsor's protocol ID
- CHUBX 2013/35
- Acronym
- MIGAT
- Status last verified
- Feb 2017
- First submitted
- 7 Oct 2014
- Last updated
- 17 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Image Processing Software to Guide Cardiac Ablation Therapy
- ClinicalTrials.gov ID
- NCT02275104
- Acronym / sponsor ID
- MIGAT / CHUBX 2013/35
- Keywords
- Ventricular arrhythmias, Persistent atrial fibrillation, Ablation guidance, Software, MRI (Magnetic resonance imaging)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 1 Sep 2014 (actual)
- Primary completion
- 21 Jul 2016 (actual)
- Study completion
- 21 Jul 2016 (actual)
- First posted
- 27 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ventricular arrhythmias | – | Device: Contrast-enhanced ECG-gated multi-detector computed tomography, Device: Magnetic resonance imaging, Device: Positron emission tomography, Device: Body surface mapping, Procedure: Cardiac ablation procedure |
| Persistent atrial fibrillation | – | Device: Magnetic resonance imaging, Device: Body surface mapping, Procedure: Cardiac ablation procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ventricular arrhythmias or persistent atrial fibrillation
Key inclusion criteria (3 listed)
- Age > 18 years old
- Body weight < 140 kg
- Indicated ablation for ventricular tachycardia or persistent atrial fibrillation
Key exclusion criteria (1 listed)
- Severe renal insufficiency defined by creatinine clearance < 30 mL/min
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contrast-enhanced ECG-gated multi-detector computed tomographyDepending 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 | Device | Ventricular arrhythmias |
| Magnetic resonance imagingDepending 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. | Device | Persistent atrial fibrillation, Ventricular arrhythmias |
| Positron emission tomographyOnly 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. | Device | Ventricular arrhythmias |
| Body surface mappingIt 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. | Device | Persistent atrial fibrillation, Ventricular arrhythmias |
| Cardiac ablation procedureVentricular 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. | Procedure or surgery | Persistent atrial fibrillation, Ventricular arrhythmias |
Primary outcome
To build MIGAT software
Time frame: 28 months
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.
To test MIGAT for real-time guidance during cardiac ablation procedures.
Time frame: 28 months
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.
2 secondary outcomes
To improve the compatibility of MIGAT with daily clinical use
Time frame: 28 months
Correlations between MIGAT predictions from non-invasive data, and ablation targets observed during invasive procedures
Time frame: 28 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventricular Arrhythmias and Persistent Atrial Fibrillation, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To build MIGAT software (time frame: 28 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2017.