Ventricular TachycardiaSoundScarNCT03862339
The SoundScar Study The SOUNDSCAR Study
An observational study of Ventricular Tachycardia and Ischemic Cardiomyopathy, run by Liverpool Heart and Chest Hospital NHS Foundation Trust at 2 sites in 2 countries.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Tachycardia, Ischemic Cardiomyopathy
- How many people
- 38 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 9 Nov 2018to 1 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with ischaemic cardiomyopathy undergoing ventricular tachycardia (VT) ablation
Who may be able to join
- 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
Show all 9Show fewer
- 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)
Who cannot join
- 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)
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United Kingdom1 site
Liverpool Heart and Chest Hospital NHS Trust
Liverpool, L14 3PE
About this study
Official title: UltraSOUND-based Characterization of Ventricular Tachycardia SCAR and Arrhythmogenic Substrate; The SOUNDSCAR Study
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
Read the 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.
- Conditions
- Ventricular Tachycardia, Ischemic Cardiomyopathy
- Keywords
- Catheter Ablation
- Medical subject headings
- Tachycardia, Ventricular
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week
Secondary outcomes (1)
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
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start9 Nov 2018
- Primary completion1 Apr 2021
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular TachycardiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liverpool Heart and Chest Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Papworth Hospital NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Saagar Mahida, MD, Principal investigator, Liverpool Heart and Chest HospitalSharad Agarwal, MD, Principal investigator, Papworth Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03862339
- Sponsor's protocol ID
- 1171
- Acronym
- SoundScar
- Status last verified
- Oct 2023
- First submitted
- 25 Feb 2019
- Last updated
- 4 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UltraSOUND-based Characterization of Ventricular Tachycardia SCAR and Arrhythmogenic Substrate; The SOUNDSCAR Study
- ClinicalTrials.gov ID
- NCT03862339
- Acronym / sponsor ID
- SoundScar / 1171
- Conditions
- Ventricular Tachycardia, Ischemic Cardiomyopathy
- Keywords
- Catheter Ablation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Liverpool Heart and Chest Hospital NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Papworth Hospital NHS Foundation Trust
- Study start
- 9 Nov 2018 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 5 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ischaemic cardiomyopathy undergoing ventricular tachycardia (VT) ablation
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Areas of abnormal contraction (hypokinesia/akinesia) as determined by ICE imaging
Time frame: 1 week
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 secondary outcome
Areas of abnormal contraction as determined by ICE imaging
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for Ventricular Tachycardia
Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
RecruitingPhase 1
A Study of SGT-501 Gene Therapy in Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)
Catecholaminergic Polymorphic Ventricular Tachycardia
Recruiting
Safety and Effectiveness of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere VT)
Ventricular Tachycardia
Active, not recruiting
Combined Pulsed Field and Radiofrequency Energy for Ablation of Ventricular Tachycardia
Ventricular Tachycardia (V-Tach)
Recruiting
SPIKE FLOW Endocardial Lead Safety and Performance Study
Acute Myocardial Infarction (AMI), Asystole
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saagar Mahida, MD principal investigator
Liverpool Heart and Chest Hospital
Sharad Agarwal, MD principal investigator
Papworth Hospital NHS Trust
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventricular Tachycardia and Ischemic Cardiomyopathy, run by Liverpool Heart and Chest Hospital NHS Foundation Trust at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Areas of abnormal contraction (hypokinesia/akinesia) as determined by ICE imaging (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2023.