Clinical Study
Clinical Study
Study 1: Vibration sensor can detect signal reflecting elevation in filling pressure
The data shows that a specific signal detected by the fiber optic sensor can differentiate the patients with elevated filing pressure.
The vibration shows moderate correation with Echo index E/e', which is usually use to estimate filling pressure.
This study demonstrates the feasibility of using our sensor technology to assess filing pressure in the future.
Study 2: NIFP VS. Echocardiography in diagnosis of elevated cardiac filling pressure
Echocardiography is the best current non-invasive tool for diagnosing elevated filling pressure.
The data in this initial study show a high agreement rate between the NIFP device and echocardiography result.
Using 18mmHg as cut-off value, the agreement rate is 83%, with 74% positive agreement rate and 86% negative agreement rate, p<0.0001. N=158.
Study 3: NIFP VS. PCWP by Right Heart Catheterization
The Swan-Ganz(SG) catheter is the gold standard.
The data demonstrate that the NIFP device presents good accuracy compared to gold standard.
Using 18mmHg as cut-off value, the accuracy is 88%, with 71% sensitivity and 91% specificity, P<0.001. N=93.
Accuracy and correlation better than state of the art non-invasive surrogate tools.
It is promising evidence that the NIFP device can be used to diagnose elevated filling pressure.
Study 4: NIFP VS. PAWP by Right Heart Catheterization
We conducted NIFP measurements in 74 patients before or after RHC. The correlation between recorded factors and PAWP values was examined.
We tested NIFP‘s performance as a predictive tool for PAWP using different thresholds 15mmHg and18mmHg.
NIFP demonstrated moderate accuracy in predicting PAWP values (all AUC > 0.75), particularly among patients without arrhythmia [AUC for Model 1 (PAWP >15): 0.80; AUC for Model 2 (PAWP >18): 0.85].
Study 5: NIFP VS. Current best clinical practices in real world
In current clinical practice, physicians use a combination of examination results to diagnose elevated filling pressure.
This evidence demonstrates that the NIFP device can provide diagnostic results consistent with physicians’ real-world practices.
The NIFP reading is higher in the acute condition patient group and significantly lower when patients are in a stable condition. The gap is distinct, allowing for clear differentiation between each group.
The device successfully differentiated between chronic and acute heart failure patients, with an AUROC of 0.874 (N = 135, p < 0.001).
hello@cardiostory.com