International Multi-center Study to Validate an Early Warning Algorithm for Worsening Heart Failure

Summary

Participation Requirements

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 ass...

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: Cohort 1 will provide the data to be used for algorithm development and training. Cohort 2 will provide data to be used for algorithm validation. 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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