The SoundScar Study The SOUNDSCAR Study

NCT03862339 | Completed DMC

• 1 other identifier: 1171
• Study Type: observational
• Target: 38
• Locations: 2 countries
• Sites: 2

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

Conditions

Ventricular Tachycardia; Ischemic Cardiomyopathy

Keywords

Catheter Ablation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Areas of abnormal contraction as determined by ICE imaging

  1 week

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with ischaemic cardiomyopathy undergoing ventricular tachycardia (VT) ablation

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Liverpool Heart and Chest Hospital NHS Foundation Trust: lead
• Papworth Hospital NHS Foundation Trust: collaborator

Study Sites (2)

Westmead Hospital

Sydney, New South Wales, Australia

Location

Liverpool Heart and Chest Hospital NHS Trust

Liverpool, L14 3PE, United Kingdom

Location

MeSH Terms

Conditions

Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Saagar Mahida, MD

  Liverpool Heart and Chest Hospital

  PRINCIPAL INVESTIGATOR

• Sharad Agarwal, MD

  Papworth Hospital NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2019
• First Posted: March 5, 2019
• Study Start: November 9, 2018
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: October 4, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1); AU (1)