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The SoundScar Study The SOUNDSCAR Study

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03862339
Acronym
SoundScar
Enrollment
38
Registered
2019-03-05
Start date
2018-11-09
Completion date
2021-04-01
Last updated
2023-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Cardiomyopathy, Ventricular Tachycardia

Keywords

Catheter Ablation

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.

Interventions

None listed

Sponsors

Papworth Hospital NHS Foundation Trust
CollaboratorOTHER_GOV
Liverpool Heart and Chest Hospital NHS Foundation Trust
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Areas of abnormal contraction (hypokinesia/akinesia) as determined by ICE imaging1 weekArea 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

MeasureTime frameDescription
Areas of abnormal contraction as determined by ICE imaging1 weekArea 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

Countries

Australia, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026