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OpenTrials
Completed

NCT Number: NCT04607265

Sudden Death Stratification

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.

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Key information

Conditions

Non-ischemic Cardiomyopathy Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Death Death, Sudden Death, Sudden, Cardiac Heart Arrest Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tachycardia Tachycardia, Ventricular

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cardiac MRI

Diagnostic Test

Comparison of scar characteristics on cardiac MRI between the two groups.

Primary outcomes

  1. Detect pro arrhythmogenic scar characteristics

    Time frame: baseline : collected at the time of the cardiac MRI

    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).

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Channel Detection to Predict Ventricular Arrhythmia in Patients With Non-ischemic Cardiomyopathy

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 29, 2020
Registry last updated
Oct 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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