The SoundScar Study The SOUNDSCAR Study

Ventricular Tachycardia Clinical Trial

— SoundScar  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03862339
• Other study ID #: 1171
• Status: Completed
• Start date: November 9, 2018
• Est. completion date: April 1, 2021

Study information

• Verified date: October 2023
• Source: Liverpool Heart and Chest Hospital NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: April 1, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cardiomyopathies
• Ischemic Cardiomyopathy
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Tachycardia

Locations

Country	Name	City	State
Australia	Westmead Hospital	Sydney	New South Wales
United Kingdom	Liverpool Heart and Chest Hospital NHS Trust	Liverpool

Sponsors (2)

Lead Sponsor	Collaborator
Liverpool Heart and Chest Hospital NHS Foundation Trust	Papworth Hospital NHS Foundation Trust

Countries where clinical trial is conducted

Australia,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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