3D Non-invasive Myocardial Electrical Propagation Mapping as a New Tool to Predict Sudden Death Risk in Patients With Hypertrophic Cardiomyopathy
NCT ID: NCT03550573
Last Updated: 2023-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2019-01-28
2022-09-23
Brief Summary
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It is a monocentric, prospective, comparative and analytical study. 20 HCM patients will be recruited in the National Reference Center for inherited cardiac diseases of Lyon. The 3D-propagation maps of 10 well phenotyped and genotyped HCM patients with previous VF (ventricular fibrillation) will be compared to 10 HCM patients without previous VF.
After consent signed, Holter ECG, scanner and CardioInsightTM 3D\_ECG mapping will be planned in the month following the inclusion. 12-lead ECG, 24h holter ECG, cardiac scanner will be performed as standard procedure of each center in the current health care of the patient.
The widespread screening of HCM patients with 3D high-density noninvasive mapping should improve the risk-benefit ratio of implantable defibrillator therapy. It is expected that more patients at risk will benefit from this device.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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hypertrophic cardiomyopathy without sudden death history
CardioInsight™ Noninvasive 3D Mapping System
The CardioInsight system uses a proprietary, single-use, disposable multi-electrode vest to capture electrical signals from the body surface. The CardioInsight software provides various cardiac signal analyses and displays interactive 3-D color maps including activation, voltage, composite and phase maps. The vest wearing is coupled with a CT scan.
This exam will be performed only at baseline visit.
hypertrophic cardiomyopathy with sudden death history
CardioInsight™ Noninvasive 3D Mapping System
The CardioInsight system uses a proprietary, single-use, disposable multi-electrode vest to capture electrical signals from the body surface. The CardioInsight software provides various cardiac signal analyses and displays interactive 3-D color maps including activation, voltage, composite and phase maps. The vest wearing is coupled with a CT scan.
This exam will be performed only at baseline visit.
Interventions
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CardioInsight™ Noninvasive 3D Mapping System
The CardioInsight system uses a proprietary, single-use, disposable multi-electrode vest to capture electrical signals from the body surface. The CardioInsight software provides various cardiac signal analyses and displays interactive 3-D color maps including activation, voltage, composite and phase maps. The vest wearing is coupled with a CT scan.
This exam will be performed only at baseline visit.
Eligibility Criteria
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Inclusion Criteria
* Patient who signed the consent.
* Patient benefiting from a social insurance system or a similar system
Exclusion Criteria
* left ventricular dilation (diastolic \>60 mm diameter) and/or left ventricular systolic dysfunction (LVEF \<55%),
* prior cardiac surgery,
* atrial fibrillation,
* renal disease (serum creatinine \>2.0 mg/dl),
* primary cardiac valve disease
* coronary artery disease
* Previous recent cardiac scan
18 Years
ALL
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Locations
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Hôpital Louis Pradel
Bron, , France
Countries
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Other Identifiers
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ID-RCB
Identifier Type: OTHER
Identifier Source: secondary_id
69HCL17_0657
Identifier Type: -
Identifier Source: org_study_id
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