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

NCT03550573 | Completed

• 2 other identifiers: 69HCL17_0657ID-RCB
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertrophic Cardiomyopathy

Keywords

Hypertrophic cardiomyopathy; sudden death; 3D mapping

Outcome Measures

Primary Outcomes (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.

  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

Study Arms (2)

hypertrophic cardiomyopathy without sudden death history

EXPERIMENTAL

Device: CardioInsight™ Noninvasive 3D Mapping System

hypertrophic cardiomyopathy with sudden death history

EXPERIMENTAL

Device: CardioInsight™ Noninvasive 3D Mapping System

Interventions

CardioInsight™ Noninvasive 3D Mapping System DEVICE

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; hypertrophic cardiomyopathy without sudden death history

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HCM patient confirmed by echocardiogram.
• Patient who signed the consent.
• Patient benefiting from a social insurance system or a similar system

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital Louis Pradel

Bron, France

Location

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic; Death, Sudden

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2018
• First Posted: June 8, 2018
• Study Start: January 28, 2019
• Primary Completion: September 23, 2022
• Study Completion: September 23, 2022
• Last Updated: January 18, 2023

Record last verified: 2023-01

Locations

FR (1)