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The study is a multi-center, prospective, non-randomized, observational study to collect data to develop and validate a machine learning algorithm for early detection of worsening heart failure events using multi-parametric sensor data from wearable data capture device The VESTA study will enroll up to 552 subjects in up to 25 centers in order to collect data on a total of at least 56 worsening heart failure events (independently adjudicated hospitalizations or unscheduled intravenous administration of decongestive drugs).The duration of follow-up per participant will be between 3-6 months.
Full description
The study is an international, multicenter, prospective, open-label, non-randomized single group study, with no control group.
The study has 2 phases: the first phase is to train and develop the automated learning algorithm; the second phase is to validate the algorithm.
The participants will be assigned into two cohorts:
It has been estimated that approximately 276 subjects are required for each cohort in order to accumulate the minimum number of cases for the study's primary objective. Sequential enrolment will be implemented by regional blocks according to an estimation of the regional distribution of subjects.The sample size and regional distribution of subjects are estimates and the study is endpoint driven to achieve at least 28 WHF events with corresponding analyzable device data. Fewer subjects may be enrolled should the required number of events be acquired at a faster rate than calculated and the regional proportions of subjects may vary according to regional enrollment rates.
All participants will undergo the same study procedures, irrespective of their cohort assignment. Each subject will receive the study device kit (garment and smart phone with charger) at enrollment and will be followed up for up to 6 months, or until at least 28 worsening heart failure (WHF) events per cohort have been acquired. Even if the required number of events have been acquired, all participants will be followed up for a minimum of at least 3 months.
The study will collect data; however no data collected by the device will be made available to clinical care personnel during the study and as such no medical action will be taken based on the device. Medical follow-up will be according to standard practice as per each investigational site, which will be documented AND there will be no additional medical intervention on the study participants. The participants are required to agree to be compliant with the use of the device.
There is no masking of device allocation or procedures. However, the clinical investigators, treating physicians and the independent clinical events adjudication committee (IEAC) members will be blinded to all sensor data throughout the study.
The investigators developing the algorithm will have no access to the validation cohort database before the parameters of the algorithm have been fixed by the training cohort.
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Inclusion criteria
18 years of age and above
New York Heart Association(NYHA) functional class II-IV
Reduced ejection fraction (HFrEF) with left ventricular ejection fraction (LVEF) ≤40%
History of chronic HF as evidenced by
At increased risk for HF decompensation as defined by
Understands the study requirements and the study procedures and provides written informed consent before any trial-specific tests or procedures are performed
Exclusion criteria
Known allergy to any component of the study device (cotton, elastane, polyester)
Current HF hospitalization due to acute de novo heart failure
Current HF decompensation due to triggers like surgery or perioperative complications, pulmonary embolic episode or acute myocardial infarction
Severe chronic kidney disease with glomerular filtration rate (GFR) <30 ml/ min/1.73 m2 and/or renal replacement therapy
Evidence of hepatic disease as determined by any one of the following: serum glutamic-oxaloacetic transaminase (SGOT/AST) or serum glutamic-pyruvic transaminase (SGPT/ALT) values exceeding 3x upper limit of normal, bilirubin >1.5 mg/dl
Body mass index (BMI)>35 kg/m2
Planned surgery or other procedures within 6 months after the inclusion
Severe uncorrected valvular heart disease, or hypertrophic obstructive cardiomyopathy, active myocarditis, constrictive pericarditis, or clinically significant congenital heart disease
Receiving mechanical circulatory support
Candidates on heart transplant list
Factors or conditions, that according to investigator assessment may affect compliance with protocol or cause confound data interpretation. Examples may include but are not limited to:
Participating in another investigational drug or device clinical trial
Pregnant or nursing
552 participants in 2 patient groups
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Central trial contact
Zarifah Reed, MD; Dominique Dury
Data sourced from clinicaltrials.gov
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