Clinical Trials Logo

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05068154
Study type Observational
Source Great Western Hospitals NHS Foundation Trust
Contact Badri Chandrasekaran
Phone +441793646313
Email [email protected]
Status Not yet recruiting
Start date November 1, 2021
Completion date May 31, 2024

See also
  Status Clinical Trial Phase
Recruiting NCT05077293 - Electronic Triggers: Better Care - HF
Recruiting NCT04475315 - Ventricular Sling for Heart Failure With Reduced Ejection Fraction N/A
Not yet recruiting NCT05034354 - Virtual Remote Physiological Monitoring Program of Children With Heart Disease N/A
Recruiting NCT04177199 - What is the Workload Burden Associated With Using the Triage HF+ Care Pathway?
Terminated NCT03615469 - Building Strength Through Rehabilitation for Heart Failure Patients (BISTRO-STUDY) N/A
Completed NCT03549169 - Decision Making for the Management the Symptoms in Adults of Heart Failure N/A
Recruiting NCT04262830 - Cancer Therapy Effects on the Heart
Withdrawn NCT03091998 - Subcu Administration of CD-NP in Heart Failure Patients With Left Ventricular Assist Device Support Phase 1
Recruiting NCT04549181 - Problem-Solving for Rural Heart Failure Dyads N/A
Completed NCT02748876 - Effect of His-Ventricular (HV) Interval Optimisation in Cardiac Resynchronisation Therapy N/A
Not yet recruiting NCT05057364 - Heart Smart: A Virtual Self-Management Program for Homebound People With Heart Failure N/A
Completed NCT03294512 - Pilot and Feasibility Study of a MAWDS (Medications, Activity, Weight, Diet and Symptoms) Heart Failure Mobile Platform N/A
Completed NCT03300791 - Predictive Models of Readmission in Heart Failure
Enrolling by invitation NCT04676100 - International CR Registry
Terminated NCT03565328 - The Effect of Nicotinamide Riboside on Skeletal Muscle Function in Heart Failure Subjects Phase 2
Terminated NCT04066738 - Scar Location and Acute Haemodynamic Response to MultiPoint Pacing Study in Patients With Ischemic Cardiomyopathy N/A
Recruiting NCT04573166 - Personalized Atrial Septostomy for Heart Failure N/A
Recruiting NCT04537104 - Remote Monitoring in Patients With Heart Failure
Active, not recruiting NCT03560167 - Early Feasibility Study of the AccuCinch® Ventricular Restoration System in Patients With Prior Mitral Valve Intervention (PMVI) and Recurrent Mitral Regurgitation N/A
Recruiting NCT05026034 - Correlation of the Non-invasive Cardiopulmonary Management (CPM) Wearable Device With Measures of Congestion in Heart Failure