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

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

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.

Study Overview

• Status: Completed
• Conditions: Hypertrophic Cardiomyopathy
• Intervention / Treatment: Device: CardioInsight™ Noninvasive 3D Mapping System

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Philippe CHEVALIER, MD PhD; Phone Number: +33 472357027; Email: philippe.chevalier@chu-lyon.fr
• Study Contact Backup: Name: Elodie MOREL, CRA; Phone Number: +33 472357027; Email: elodie.morel01@chu-lyon.fr

Study Locations

• France
  • Bron, France
    • Hopital Louis Pradel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Month 1

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2019
• Primary Completion (Actual): September 23, 2022
• Study Completion (Actual): September 23, 2022

Study Registration Dates

• First Submitted: May 25, 2018
• First Submitted That Met QC Criteria: June 7, 2018
• First Posted (Actual): June 8, 2018

Study Record Updates

• Last Update Posted (Actual): January 18, 2023
• Last Update Submitted That Met QC Criteria: January 16, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: 3D mapping; Hypertrophic cardiomyopathy; sudden death
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Death; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Hypertrophy; Cardiomyopathies; Cardiomyopathy, Hypertrophic; Death, Sudden
• Other Study ID Numbers: 69HCL17_0657; ID-RCB (Other Identifier: 2023-A01937-38)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No