3D Non-invasive Myocardial Electrical Propagation Mapping as a New Tool to Predict Sudden Death Risk in Patients With Hypertrophic Cardiomyopathy (3D-CMH)
Primary Purpose
Hypertrophic Cardiomyopathy
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
CardioInsight™ Noninvasive 3D Mapping System
Sponsored by
About this trial
This is an interventional diagnostic trial for Hypertrophic Cardiomyopathy focused on measuring Hypertrophic cardiomyopathy, sudden death, 3D mapping
Eligibility Criteria
Inclusion criteria :
- HCM patient confirmed by echocardiogram.
- Patient who signed the consent.
- Patient benefiting from a social insurance system or a similar system
Exclusion Criteria:
- pregnant women,
- 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
Sites / Locations
- Hôpital Louis Pradel
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
hypertrophic cardiomyopathy without sudden death history
hypertrophic cardiomyopathy with sudden death history
Arm Description
Outcomes
Primary Outcome Measures
Identification of specific markers of risk of sudden death in HCM patients from the maps created by the combination of CT and signal data.
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 use of the CardioInsight system is correlated with a CT scan.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03550573
Brief Title
3D Non-invasive Myocardial Electrical Propagation Mapping as a New Tool to Predict Sudden Death Risk in Patients With Hypertrophic Cardiomyopathy
Acronym
3D-CMH
Official Title
3D Non-invasive Myocardial Electrical Propagation Mapping as a New Tool to Predict Sudden Death Risk in Patients With Hypertrophic Cardiomyopathy: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
January 28, 2019 (Actual)
Primary Completion Date
September 23, 2022 (Actual)
Study Completion Date
September 23, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Hypertrophic cardiomyopathy (HCM) is very common. The thickened heart muscle can disrupt the normal functioning of the heart's electrical system, resulting in fast or irregular heartbeats. Today, there are no reliable means to identify HCM patients at risk of sudden death. The CardioInsight™ has recently been developed by Medtronic for non-invasive advanced cardiac mapping system. The CardioInsight™ Noninvasive 3D Mapping System is a non-invasive mapping system that collects chest ECG signals and combines these signals with CT scan data to produce and display simultaneous, bi-atrial and biventricular, 3-D cardiac maps.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertrophic Cardiomyopathy
Keywords
Hypertrophic cardiomyopathy, sudden death, 3D mapping
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
hypertrophic cardiomyopathy without sudden death history
Arm Type
Experimental
Arm Title
hypertrophic cardiomyopathy with sudden death history
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
CardioInsight™ Noninvasive 3D Mapping System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Identification of specific markers of risk of sudden death in HCM patients from the maps created by the combination of CT and signal data.
Description
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 use of the CardioInsight system is correlated with a CT scan.
Time Frame
Month 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria :
HCM patient confirmed by echocardiogram.
Patient who signed the consent.
Patient benefiting from a social insurance system or a similar system
Exclusion Criteria:
pregnant women,
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
Facility Information:
Facility Name
Hôpital Louis Pradel
City
Bron
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
3D Non-invasive Myocardial Electrical Propagation Mapping as a New Tool to Predict Sudden Death Risk in Patients With Hypertrophic Cardiomyopathy
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