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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03862339




Registration number
NCT03862339
Ethics application status
Date submitted
25/02/2019
Date registered
5/03/2019
Date last updated
2/11/2020

Titles & IDs
Public title
The SoundScar Study The SOUNDSCAR Study
Scientific title
UltraSOUND-based Characterization of Ventricular Tachycardia SCAR and Arrhythmogenic Substrate; The SOUNDSCAR Study
Secondary ID [1] 0 0
1171
Universal Trial Number (UTN)
Trial acronym
SoundScar
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ventricular Tachycardia 0 0
Ischemic Cardiomyopathy 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
1 week
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
1 week

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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)

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Westmead Hospital - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
United Kingdom
State/province [1] 0 0
Liverpool

Funding & Sponsors
Primary sponsor type
Other
Name
Liverpool Heart and Chest Hospital NHS Foundation Trust
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Papworth Hospital NHS Foundation Trust
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/show/NCT03862339
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Saagar Mahida, MD
Address 0 0
Liverpool Heart and Chest Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Michael Noorzadeh
Address 0 0
Country 0 0
Phone 0 0
01516001242
Fax 0 0
Email 0 0
Michael.Noorzadeh@lhch.nhs.uk
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03862339