Originally published in Mass Device
Corvia Medical said it launched a heart failure device trial that will include the collection and analysis of data with physIQ’s continuous remote monitoring platform.
The Phase III trial is designed to evaluate the efficacy of Tewksbury, Mass.-based Corvia’s interatrial shunt in patients with heart failure. The randomized, controlled, double-blinded study includes plans to provide patients with a wearable biosensor and mobile data hub to establish a personalized pre-intervention baseline prior to randomization, then for 12 months after implantation.
Patients wearing the biosensor will generate data with a six-minute walking test evaluation and Kansas City Cardiomyopathy Questionnaire assessments. Data from the biosensor will stream to the cloud for physIQ’s artificial intelligence-based analytics system, with the goal of assisting in demonstrating change in cardiopulmonary function, supporting novel clinical endpoints and potentially transforming how heart failure clinical trials operate.
The Reduce LAP-HF II clinical trial was launched in November 2017 and met its primary endpoints in August 2018. Corvia expects to complete enrollment in 2020 and, upon conclusion, the company anticipates the study will have generated more than 2 million hours of continuous, annotated, clinical-level physiological data.
“Heart failure is a major global health problem and HF with preserved and mid-range ejection fraction remains a large unmet need,” CMO Dr. Jan Komtebedde said in prepared remarks. “At Corvia Medical, we are evaluating a first-in-class approach to treating heart failure and, as such, see a powerful opportunity to include digital data to support IASD efficacy. It’s in this innovative spirit that we chose to partner with physIQ and bring novel real-world insights into how to assess therapeutic impact.”
“Think about a race car. The driver is continuously getting actionable performance information throughout the race and using that insight to direct how to optimize the performance of the vehicle,” added physIQ CTO Matt Pipke. “However, if you applied the traditional model of healthcare to that scenario, the driver would only get information when periodically pulled over for a pit stop. It’s easy to see how that would fail; why do we accept it in healthcare? With our solution, we are developing biomarkers with life science companies that allow them to quantify clinical impact on a continuous basis – and this insight can be applied in a clinical context to support regulatory submissions or to demonstrate real world evidence to payers and providers.”