The SoundScar Study The SOUNDSCAR Study

NCT ID: NCT03862339

Last Updated: 2023-10-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 38 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-11-09
• Study Completion Date: 2021-04-01

Brief Summary

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

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.

Conditions

Ventricular Tachycardia; Ischemic Cardiomyopathy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Papworth Hospital NHS Foundation Trust

OTHER_GOV

Sponsor Role: collaborator

Liverpool Heart and Chest Hospital NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Saagar Mahida, MD

Role: PRINCIPAL_INVESTIGATOR

Liverpool Heart and Chest Hospital

Sharad Agarwal, MD

Role: PRINCIPAL_INVESTIGATOR

Papworth Hospital NHS Trust

Locations

Westmead Hospital

Sydney, New South Wales, Australia

Liverpool Heart and Chest Hospital NHS Trust

Liverpool, , United Kingdom

Countries

Australia; United Kingdom

Other Identifiers

1171

Identifier Type: -

Identifier Source: org_study_id