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Completed

NCT Number: NCT03862339

The SoundScar Study The SOUNDSCAR Study

Prospective, Non-randomized, Single-arm Study to assess the accuracy of intracardiac echocardiography (ICE) for characterization of arrhythmogenic substrate in patients with ischaemic cardiomyopathy undergoing ventricular tachycardia (VT) ablation

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Westmead Hospital, Sydney, New South Wales, Australia

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About this study

ICE imaging during VT ablation is currently largely used for definition of cardiac anatomy. The role of the technique to specifically define scar and arrhythmogenic substrate has not been systematically evaluated. The aim is to assess the efficacy of the technique to accurately define the arrhythmogenic substrate.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Prior heart attack (myocardial infarction) with evidence from prior non-invasive imaging demonstrating regions of the heart with reduced heart muscle function (myocardial hypokinesia/akinesia/thinning) in the absence of a non-heart attack-related (non-ischaemic) cause
  • Age over 18 years
  • One of the following abnormal heart rhythm (VT) events within last 6 months:
  • ≥3 episodes of VT treated with therapeutic rapid pacing from an implantable cardiac defibrillator (antitachycardia pacing [ATP])
  • ≥1 appropriate shocks from an implantable cardiac defibrillator
  • ≥3 episodes of abnormal heart rhythm (VT) within 24 hours
  • Sustained VT below the detection rate of the implantable cardiac defibrillator (documented by ECG/cardiac monitor)
  • Sustained abnormal heart rhythm (VT) in the absence of ICD which is documented by ECG/cardiac monitor
  • Patients in whom ICE imaging is planned for the clinical VT ablation procedure (clinical indication)

Exclusion criteria

  • Patient unable or unwilling to provide informed consent.
  • Acute heart attack (acute coronary syndrome with acute thrombus diagnosed by coronary angiography, or dynamic ST segment changes demonstrated on ECG) or another reversible cause of abnormal heart rhythm (VT) - e.g. electrolyte abnormalities or drug-induced abnormal heart rhythms
  • Ineligible for ablation (known to have protruding clot in the chamber of interest (left ventricular thrombus), or have implanted mechanical aortic and mitral valves)
  • Had recent coronary bypass surgery (< 3 months) or percutaneous coronary intervention (<3 months)
  • Pregnant patients (pregnancy test will be performed in patients who are of childbearing age who are not on an effective contraceptive prior to all VT ablation procedures)
  • Had recent coronary bypass surgery (< 3 months) or percutaneous coronary intervention (<3 months)

Treatment and study plan

Primary outcomes

  1. Areas of abnormal contraction (hypokinesia/akinesia) as determined by ICE imaging

    Time frame: 1 week

    Area with abnormal contraction as correlated the findings on voltage mapping (low voltage) of the left ventricle in patients with a prior myocardial infarction undergoing VT ablation.

Secondary outcomes

  1. Areas of abnormal contraction as determined by ICE imaging

    Time frame: 1 week

    Area of abnormal contraction correlating with the findings on voltage mapping (local abnormal ventricular activities) of the left ventricle in patients with a prior myocardial infarction undergoing VT ablation

Sponsors and collaborators

Lead sponsor

Liverpool Heart and Chest Hospital NHS Foundation Trust

Other

Collaborators

  • Papworth Hospital NHS Foundation Trust

Registry information

Official study title

UltraSOUND-based Characterization of Ventricular Tachycardia SCAR and Arrhythmogenic Substrate; The SOUNDSCAR Study

Acronym: SoundScar

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Mar 5, 2019
Registry last updated
Oct 4, 2023

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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