Corvia Medical is actively enrolling and sponsoring a first-of-its-kind 100+ site, global, Phase 3 clinical trial leveraging continuous multivariate wearable sensor data and artificial intelligence (AI) based analytics to evaluate the clinical efficacy of it’s InterAtrial Shunt Device (IASD®) in patients with heart failure. In addition to measuring traditional heart failure endpoints, Corvia has partnered with PhysIQ to leverage its remote monitoring platform which will continuously collect physiological data and utilize AI to assess the therapeutic impact and disease progression.
“Heart Failure is a major global health problem and HF with preserved and mid-range ejection fraction remains a large unmet need. 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.”– Dr. Jan Komtebedde, Chief Medical Officer, Corvia Medical
In the randomized controlled double-blinded study, enrolled patients are provided with a wearable biosensor and mobile data transfer hub. Each patient wears the biosensor prior to study randomization to establish a personalized pre-intervention baseline and then for up to 12 months after the device implant. Data will continuously stream from the biosensor to the cloud for retrospective analysis with PhysIQ’s proprietary analytics platform. With real-world data and personalized analytics, the objective is to assist in demonstrating a meaningful change in cardiopulmonary function and support novel clinical endpoints.
Of particular note in the REDUCE LAP HF-II study is the fact that the continuous biosensor data and Artificial Intelligence analytics will be generated in conjunction with the periodic evaluation of the six-minute walking distance test (6MWDT) and Kansas City Cardiomyopathy Questionnaire (KCCQ) assessments. By integrating these traditional markers of heart failure, novel continuous multivariate biosensor data, and hard clinical outcomes, there is an extraordinary opportunity to transform how heart failure clinical trials are designed, implemented, and evaluated.
“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.”– Matt Pinpke, Chief Technology Officer, PhysIQ
The study is anticipated to complete enrollment in 2020 and, upon conclusion, will generate more than 2 million hours of continuous, annotated, clinical-level physiological data.
About Corvia Medical, Inc.
Corvia Medical, Inc. is dedicated to revolutionizing the treatment of heart failure with first-in-class transcatheter structural heart devices. Privately held, the company is backed by Third Rock Ventures, General Catalyst Partners, AccelMed, Lumira Ventures, Edwards Lifesciences and an undisclosed strategic investor.
PhysIQ is a company dedicated to enabling proactive care delivery models through pinpointIQ™, its highly scalable cloud-based platform for personalized physiology analytics. Our FDA 510(k)-cleared data analytics platform is designed to process multiple vital signs from wearable sensors to create a personalized dynamic baseline for each individual. By mapping vital sign relationships this way, physIQ’s analytics detect subtle deviations that may be a precursor to disease exacerbation or change in health. With applications in both healthcare and clinical trial support, PhysIQ is transforming continuous physiological data into insight for providers, health systems, payers and pharmaceutical, and medical device companies.