Status:
COMPLETED
The SoundScar Study The SOUNDSCAR Study
Lead Sponsor:
Liverpool Heart and Chest Hospital NHS Foundation Trust
Collaborating Sponsors:
Papworth Hospital NHS Foundation Trust
Conditions:
Ventricular Tachycardia
Ischemic Cardiomyopathy
Eligibility:
All Genders
18+ years
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 u...
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 systematical...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
November 9 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2021
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT03862339
Start Date
November 9 2018
End Date
April 1 2021
Last Update
October 4 2023
Active Locations (2)
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1
Westmead Hospital
Sydney, New South Wales, Australia
2
Liverpool Heart and Chest Hospital NHS Trust
Liverpool, United Kingdom, L14 3PE