3D-CMH: 3D Non-invasive Myocardial Electrical Propagation Mapping as a New Tool to Predict Sudden Death Risk in Patients With Hypertrophic Cardiomyopathy

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Recruiting

CT.gov ID

NCT03550573

Collaborator

(none)

Enrollment

Location

Arms

43.1

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertrophic Cardiomyopathy	Device: CardioInsight™ Noninvasive 3D Mapping System	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

33 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

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

Actual Study Start Date :

Jan 28, 2019

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: hypertrophic cardiomyopathy without sudden death history	Device: 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.
Experimental: hypertrophic cardiomyopathy with sudden death history	Device: 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.

Arm

Intervention/Treatment

Experimental: hypertrophic cardiomyopathy without sudden death history

Device: 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.

Experimental: hypertrophic cardiomyopathy with sudden death history

Device: CardioInsight™ Noninvasive 3D Mapping System

Outcome Measures

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. [Month 1]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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