The SoundScar Study The SOUNDSCAR Study (SoundScar)

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

Study Overview

• Status: Completed
• Conditions: Ventricular Tachycardia; Ischemic Cardiomyopathy

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 38

Contacts and Locations

• Study Contact: Name: Michael Noorzadeh; Phone Number: 01516001242; Email: Michael.Noorzadeh@lhch.nhs.uk

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia
      • Westmead Hospital
• United Kingdom
  • Liverpool, United Kingdom, L14 3PE
    • Liverpool Heart and Chest Hospital NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with ischaemic cardiomyopathy undergoing ventricular tachycardia (VT) ablation

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Areas of abnormal contraction (hypokinesia/akinesia) as determined by ICE imaging	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.	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Areas of abnormal contraction as determined by ICE imaging	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	1 week

Collaborators and Investigators

• Sponsor: Liverpool Heart and Chest Hospital NHS Foundation Trust
• Collaborators: Papworth Hospital NHS Foundation Trust
• Investigators: Principal Investigator: Saagar Mahida, MD, Liverpool Heart and Chest Hospital; Principal Investigator: Sharad Agarwal, MD, Papworth Hospital NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2018
• Primary Completion (Actual): April 1, 2021
• Study Completion (Actual): April 1, 2021

Study Registration Dates

• First Submitted: February 25, 2019
• First Submitted That Met QC Criteria: March 4, 2019
• First Posted (Actual): March 5, 2019

Study Record Updates

• Last Update Posted (Actual): October 4, 2023
• Last Update Submitted That Met QC Criteria: October 3, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Catheter Ablation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Tachycardia; Tachycardia, Ventricular; Cardiomyopathies
• Other Study ID Numbers: 1171 (Comité d'Ethique de la Recherche Biomédicale (CERB))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No