The REDUCE LAP HF-II study will combine Corvia Medical's InterAtrial Shunt Device (IASD), pictured here, with physIQ's continuous monitoring platform to evaluate the device's efficacy in patients with heart failure. Image courtesy of Corvia Medical.
September 12, 2019 — Corvia Medical has sponsored and is actively enrolling patients in a heart failure (HF) device trial that, in addition to measuring traditional heart failure endpoints, includes collecting and analyzing biosensor data with physIQ’s continuous remote monitoring platform. The clinical trial is designed to evaluate the clinical efficacy of Corvia’s InterAtrial Shunt Device (IASD) in patients with heart failure and is enrolling patients at more than 100 sites worldwide. Of note, the pivotal Phase 3 study design mirrors commentary within a recent U.S. Food and Drug Administration (FDA) Public Workshop and FDA Draft Guidance for Industry related to using biosensor data.
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 continuously streams from the biosensor to the cloud for retrospective analysis with physIQ’s proprietary artificial intelligence (AI)-based analytics. With these novel real-world data and personalized analytics, the objective is to assist in demonstrating meaningful change in cardiopulmonary function and support novel clinical endpoints – a focus of FDA’s recent public workshop entitled “Endpoints for Drug Development in Heart Failure.” At the workshop, leading experts discussed the promise of biosensor data in heart failure trials to assess changes in physical function and quality of life.
Of particular note in the REDUCE LAP HF-II study is the fact that the continuous biosensor data and AI 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, Corvia believes there is opportunity to transform how heart failure clinical trials are designed, implemented and evaluated.
With this approach, it is possible to continuously collect physiological data and utilize AI to assess therapeutic impact and disease progression in a way that can revolutionize how we think about clinical evidence.
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.
The Interatrial Shunt Device is a transcatheter device approved in the European Union to treat heart failure with preserved (HFpEF) or mid-range ejection fraction (HFmrEF). After creating a small opening in the atrial septum, the IASD implant is deployed, forming a passage between the left and right atria that enables the left atrium to decompress at rest and during physical activity, with the aim of lowering left atrial pressure. By facilitating continuous and dynamic decompression of the left atrium, the IASD aims to improve heart failure symptoms and quality of life, decrease heart failure hospitalization rates, and reduce the overall cost burden of managing heart failure patients.
For more information: www.corviamedical.com, www.physiq.com