Ventric Health has commenced enrolment in a large study comparing the company’s non-invasive Vivio system with the CardioMEMS (Abbott) system to determine their respective abilities to effectively measure heart failure (HF) status over time and enable physicians to reduce patient hospitalisations and death.
Patients with advanced HF at ongoing risk of hospitalisation are frequently implanted with a device to measure their HF status. These implants require an invasive procedure, presenting potential health risks. The devices measure pulmonary artery pressure (PAP), which is a surrogate for the gold-standard HF measure of left ventricular end-diastolic pressure (LVEDP).
The FDA-approved Vivio system non-invasively measures LVEDP in a simple, five-minute test, with the goal of early HF detection and earlier intervention before quality of life deterioration. The system is portable and entirely non-invasive, allowing for monitoring of patients in the home environment or in the primary care environment.
The new study will compare the Vivio system to the CardioMEMS implant. The study will enrol up to 500 patients at up to 20 sites.
“We are excited to examine how LVEDP measures obtained non-invasively compare to the standard HF proxy measure of PAP obtained invasively. If the Vivio technology proves successful, it has the potential to enable physicians to optimally manage patients with HF and may lead us to re-examine whether an invasive procedure is necessary to achieve the same clinical outcomes,” said Kevin Shah (Memorial Care Heart and Vascular Institute, Long Beach, USA), principal investigator in the study.
“The Vivio system is designed to be quick and simple to use, enabling wider access to HF detection and monitoring in both a primary care setting and potentially at home, as will be explored in this study. Empowering patients to easily and accurately monitor their own HF status, without the risks associated with an invasive device, presents an intriguing alternative that could benefit both physicians and their patients, and improve cost-effectiveness in the healthcare system,” said Sean Brady, chief executive officer of Ventric Health.
