Pivotal study for noninvasive PH test is now underway
Study compares Sensydia's CPS technology to right heart catheterization
The first patient has been enrolled in a pivotal study testing the accuracy of Sensydia’s noninvasive Cardiac Performance System (CPS) for measuring cardiovascular function, including pulmonary artery pressure, a key metric used to diagnose and monitor pulmonary hypertension (PH).
The multi-center, observational trial (NCT06870591) will compare CPS to right heart catheterization (RHC), an invasive gold-standard test used to measure pulmonary artery pressure. Findings will support the company in its efforts to seek regulatory approval and commercialization of CPS in the U.S.
The study hopes to enroll 600 adults who are scheduled to undergo RHC. It plans to include a diverse group of participants with a variety of conditions.
“Enrolling the first patient in our pivotal study marks a significant milestone for Sensydia as we advance our mission to transform cardiac care,” Anthony Arnold, president and CEO of Sensydia, said in a company press release.
PH is characterized by elevated pressure in the vessels supplying blood from the heart to the lungs, called the pulmonary arteries. This puts excess strain on the heart, which can eventually lead to heart failure.
Echocardiography, right heart catheterization used to diagnose PH
Diagnosing and monitoring PH commonly involves two specialized techniques: echocardiography, which uses sound waves to visualize the heart’s structure and function; and RHC, which measures pulmonary artery pressure via a thin tube, or catheter, that’s inserted into a vein.
These techniques are resource-intensive and need to be performed at medical facilities by providers with appropriate expertise. They also capture data only at a single point in time.
CPS is a noninvasive platform designed to provide real-time measures of cardiovascular function, including pulmonary artery pressure, with similar accuracy to RHC. The objective is to help physicians more easily evaluate heart function and make effective treatment decisions for people with heart failure and PH.
With the system, biosensors are placed on the body that capture real-time information about the heart’s sounds and electrical activity. The data are then analyzed and interpreted using artificial intelligence-powered algorithms.
The system can be trained to assess a variety of hemodynamic parameters, or measures related to blood flow. According to the company, CPS assessments are fast and safe, and can be repeated as often as needed. They also have the advantage of being less costly than RHC and can be performed by healthcare professionals with minimal training.
“We believe CPS has the potential to provide clinicians with critical hemodynamic information without the risks associated with invasive procedures,” Arnold said.
Clinical studies planned to support approval of CPS technology
Sensydia’s first-generation hardware was granted marketing clearance from U.S. regulators in 2018 specifically for measuring ejection fraction, a key indicator of heart failure that assesses how much blood the heart can pump out in one beat. Now, the company is working on additional clinical studies to support approval of its full CPS technology.
A number of studies testing the technology have been completed in the last few years. Sensydia recently presented data demonstrating the ability of CPS to accurately measure pulmonary artery pressure with strong diagnostic accuracy.
The ongoing pivotal study is comparing the accuracy of CPS in measuring hemodynamic parameters, including pulmonary artery pressure, against RHC. Participants will undergo a single CPS assessment immediately before their scheduled RHC.
“The ability to obtain accurate hemodynamic assessments non-invasively will significantly impact how we manage patients with heart failure and pulmonary hypertension,” said James D. Murphy, MD, principal investigator at the study’s first site, Huntsville Hospital Heart Center in Alabama. “We are excited to participate in this important study evaluating CPS.”
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