Ventricular Tachycardia Clinical Trial
— SoundScarOfficial title:
UltraSOUND-based Characterization of Ventricular Tachycardia SCAR and Arrhythmogenic Substrate; The SOUNDSCAR Study
NCT number | NCT03862339 |
Other study ID # | 1171 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | November 9, 2018 |
Est. completion date | April 1, 2021 |
Verified date | October 2023 |
Source | Liverpool Heart and Chest Hospital NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
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) |
Country | Name | City | State |
---|---|---|---|
Australia | Westmead Hospital | Sydney | New South Wales |
United Kingdom | Liverpool Heart and Chest Hospital NHS Trust | Liverpool |
Lead Sponsor | Collaborator |
---|---|
Liverpool Heart and Chest Hospital NHS Foundation Trust | Papworth Hospital NHS Foundation Trust |
Australia, United Kingdom,
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 |
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