Clinical validation of a first-of-its-kind intracardiac pressure monitor - Brazil & Sweden

Purpose and goal:

The focus of this project is a clinical study in the region of São Paulo, Brazil. The project partners include Acorai AB (SME, Sweden), Raras CRO (SME, Brazil) and Instituto Dante Pazzanese de Cardiologia (Research Institution, Brazil). Previous clinical studies has been done on two Swedish hospitals, with clinical gold standard equivalent results.

To ensure that these results can be generalized over larger and more diverse population, Acorai will validate the solution in clinical studies in multiple countries, including this project in a Brazilian setting. Expected results and effects:

The Acorai Heart Monitor and the SAVE Sensor System is built with proprietary technology that requires the input of reliable data. The hypothesis of this project is that a clinical study in a Brazilian setting will increase the diversity of enrolled patients, improving the accuracy of the device and creating a broader and more robust datasets in the continued development of the machine learning models underlying the solution.

This project will provide datasets for the training of the machine learning system, clinical validation, and increase our chances of regulatory approvals. Approach and implementation:

The project was suppose to start 2023-07-03, continue until 2024-12-31 and be divided into 4 WPs. See ´Change request´. WP-1: Setup Clinical Study 1.1: Establishment of readiness 1.2: Setup of the clinical study 1.3: Finalization of Setup WP-2: Execution Clinical Study (2.1) 2.2: Mid-study review 2.3: End-study review

WP-3: Closure Clinical Study (3.1) 3.2: Clinical Study Report 3.3: Ethical Committee communications 3.4: Delivery of results to machine learning and regulatory teams WP-4: Project Management 4.1: Monthly WP leadership meeting 4.2: End-project discussions