An observational study in Heart Failure, sponsored by Great Western Hospitals NHS Foundation Trust. Status unknown at 2 sites in United Kingdom. Open to participants aged 18 Years to 110 Years. Per ClinicalTrials.gov, last updated 2021-10-05.
Sponsored by Great Western Hospitals NHS Foundation Trust · Observational
It is hypothesised that the MyoVista wavECG has the potential to show non inferior sensitivity and specificity compared to the current heart failure pathway screening tools of BNP/NT-proBNP and 12 lead resting ECG, but has the advantage of providing a single, familiar, inexpensive point of care test which provides point of care results and can act as a prescreen, or in circumstances replacement to BNP/NTpro-BNP testing, and eliminate a proportion of the unnecessary testing and echo referrals.
A comparative performance analysis of the modalities will form the basis for the study with subsequent reporting on the financial impact and societal benefits of any potential pathway change.
This is a multi-center, non-interventional, single arm, non-inferiority clinical study of the MyoVista wavECG ability to identify primary care patients for referral to secondary care for diagnosis of heart failure (as defined by BSE (British Society of Echocardiography) guidelines for echo), in direct comparison to BNP/NT-proBNP. The study will be conducted at a maximum of 10 investigational secondary care sites within the United Kingdom, and some/all referring primary care centres for each site. Study subjects presenting at primary care with shortness of breath, risk factors for and/or suspicion of heart failure will be referred to secondary care for 2D transthoracic echocardiogram based on borderline and abnormal BNP/NT-proBNP results as part of the current heart failure pathway as defined by the NICE (National Institute for Health and Care Excellence) guidelines, with the MyoVista wavECG used for the conventional 12 lead ECG reporting and comparison purposes only. MyoVista wavECG results will not be used in the diagnosis of a patient, and/or for the basis of a patient referral to echocardiography for the study duration. In commercial use the MyoVista wavECG will be intended for use in a population of patients being considered for such a referral by providing CWT (Continuous Wavelet Transform) and AI (Artificial Intelligence) derived informatics surrounding an overall summary of left ventricular relaxation abnormalities (High Negative, Negative, Borderline, Positive and Highly Positive). The design of this study will allow for an appropriate evaluation of safety and effectiveness for that population.
The study duration will consist of a single visit for all study subjects, after which the subject's participation in the trial will conclude unless longitudinal study inclusion criteria met and agreed at enrollment (Normal BNP/NT-proBNP, MyoVista wavECG result Negative, Borderline, Positive, Highly Positive).
All study subjects will provide written informed consent for the procedures consistent with the study protocol.
5,697 studies on the registry are indexed under Heart Failure; 1,219 are open to participants now.
This study's planned enrollment of 1,200 is above the median of 200 across 1,678 observational studies indexed under Heart Failure.
Browse Heart Failure studies →This is the only study on the registry with Great Western Hospitals NHS Foundation Trust as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Subject recruitment will include individuals presenting with shortness of breath and with risk factors for and/or suspicion of heart failure, who are to be screened as per the UK National Institute for Care and Clinical Excellence (NIICE) guidelines using a conventional 12 lead resting ECG, BNP/NT-proBNP and referred for echocardiography as part of their standard care.
Exclusion Criteria:
The MyoVista wavECG Device uses wavelet signal processing to extract frequency information from the acquired 12-lead ECG signal which is then analysed using artificial intelligence to provide information relating to left ventricular relaxation abnormalities
Non-Inferior Sensitivity (%) and Specificity (%) performance of the MyoVista wavECG compared to BNP/NT-proBNP
Non-Inferior sensitivity/specificity performance of the MyoVista wavECG to identify patients requiring referral to echo for heart failure diagnosis, compared to the BNP/NT-proBNP measurement
Time frame: 6 months for data collection
Non-Inferior PPV (%) and NPV (%) performance of the MyoVista wavECG compared to BNP/NT-proBNP
Non-Inferior PPV/NPV performance of the MyoVista wavECG to identify patients requiring referral to echo for heart failure diagnosis, compared to the BNP/NT-proBNP measurement
Time frame: 6 months for data collection
Economic analysis of the MyoVista wavECG test compared to BNP/NT-proBNP (£GBP)
Economic analysis of the MyoVista wavECG as a patient referral to echo tool for heart failure diagnosis compared to BNP/NT-proBNP testing, based on performance improvements (sensitivity and specificity) from MyoVista wavECG. Comparison of referral cost implications of improved risk stratification to include MyoVista waveECG test cost/primary care staff time/cardiology staff time/cost of performing echo vs BNP/NT-proBNP test cost/primary care staff time/cardiology staff time/cost of performing echo
Time frame: 6 months for data collection
Sensitivity (%) and Specificity (%) performance of MyoVista wavECG to identify patients with systolic dysfunction
MyoVista wavECG ability to identify patients with left ventricular relaxation abnormalities associated impaired systolic function as defined by reduced ejection fraction (\<50%)
Time frame: 6 months for data collection
PPV (%) and NPV (%) performance of MyoVista wavECG to identify patients with systolic dysfunction
MyoVista wavECG ability to identify patients with left ventricular relaxation abnormalities associated impaired systolic function as defined by reduced ejection fraction (\<50%)
Time frame: 6 months for data collection
Sensitivity (%) and Specificity (%) performance of the MyoVista wavECG predictive ability
Patients who returned a normal BNP/NT-proBNP test will be tracked for future visits to primary/secondary care related to cardiovascular disease for a period of 24 mths, allowing an evaluation of the MyoVista wavECG's ability to predict and identify patients likely to experience future disease onset
Time frame: 24 months from subject enrolment
PPV (%) and NPV (%) performance of the MyoVista wavECG predictive ability
Patients who returned a normal BNP/NT-proBNP test will be tracked for future visits to primary/secondary care related to cardiovascular disease for a period of 24 mths, allowing an evaluation of the MyoVista wavECG's ability to predict and identify patients likely to experience future disease onset
Time frame: 24 months from subject enrolment
Plan to share: Undecided
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This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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