The SoundScar Study The SOUNDSCAR Study (NCT03862339) | Clinical Trial Compass
CompletedNot Applicable
The SoundScar Study The SOUNDSCAR Study
Australia, United Kingdom38 participantsStarted 2018-11-09
Plain-language 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
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 val…
What they're measuring
1
Areas of abnormal contraction (hypokinesia/akinesia) as determined by ICE imaging
Timeframe: 1 week
Trial details
NCT IDNCT03862339
SponsorLiverpool Heart and Chest Hospital NHS Foundation Trust