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

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ClinicalTrials.gov Identifier: NCT03550573
Recruitment Status : Recruiting
First Posted : June 8, 2018
Last Update Posted : December 9, 2021
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Study Description
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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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 28, 2019
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Identification of specific markers of risk of sudden death in HCM patients from the maps created by the combination of CT and signal data. [ Time Frame: 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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03550573


Contacts
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Contact: Philippe CHEVALIER, MD PhD 472357027 ext +33 philippe.chevalier@chu-lyon.fr
Contact: Elodie MOREL, CRA 472357027 ext +33 elodie.morel01@chu-lyon.fr

Locations
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France
Hôpital Louis Pradel Recruiting
Bron, France
Contact: Philippe Chevalier, Pr         
Contact: Elodie MOREL, CRA       elodie.morel01@chu-lyon.fr   
Sponsors and Collaborators
Hospices Civils de Lyon
More Information
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03550573    
Other Study ID Numbers: 69HCL17_0657
ID-RCB ( Other Identifier: 2018-A00211-54 )
First Posted: June 8, 2018    Key Record Dates
Last Update Posted: December 9, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
Hypertrophic cardiomyopathy
sudden death
3D mapping
Additional relevant MeSH terms:
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Cardiomyopathies
Cardiomyopathy, Hypertrophic
Hypertrophy
Death, Sudden
Heart Diseases
Cardiovascular Diseases
Death
 Pathologic Processes
Pathological Conditions, Anatomical
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Aortic Valve Disease
Heart Valve Diseases