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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04607265
Other study ID # 69HCL20_0838
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2017
Est. completion date December 1, 2019

Study information

Verified date September 2020
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Sudden cardiac death (SCD) risk stratification is a challenge in non-ischemic cardiomyopathy (NICM). The underlying mechanism of monomorphic ventricular tachycardia (VT) is mostly scar related. While electrophysiological mechanisms underlying ventricular arrhythmia are well known, late gadolinium enhanced (LGE) cardiac MRI-3D reconstructions are now able to guide VT ablation procedures. Such exam may help in identifying specific properties of scar at risk of malignant arrhythmia.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date December 1, 2019
Est. primary completion date December 1, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Adult with NICM - Previous history of ventricular tachycardia (VT) and no previous history of VT Exclusion Criteria: - Inherited cardiomyopathies - Previous history of myocarditis WITHOUT oedema/scar at the MRI

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Cardiac MRI
Comparison of scar characteristics on cardiac MRI between the two groups.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Outcome

Type Measure Description Time frame Safety issue
Primary Detect pro arrhythmogenic scar characteristics The outcomes will aim to provide scar characteristics from 3D cardiac MRI reconstructions to detect pro arrhythmic properties in NICM patients. Comparisons between NICM patients who experienced VT ablation and NICM patients without history of ventricular arrhythmia will be made.
In both groups, Primary outcome will aim to measure the number of the conducting channels into scars (n).
baseline : collected at the time of the cardiac MRI
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