NCT06649435

Seerlinq: Non-invasive LVFP Monitoring in HF

Seerlinq: a Non-invasive System for Remote Monitoring of Left Ventricular Filling Pressure in Heart Failure Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 131 (actual)
• Sponsor: Seerlinq s. r. o. · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

Left ventricular filling pressure (LVFP) monitoring has been associated with improved quality of life, survival and reduced hospitalization rates. However, current LVFP monitoring methods are invasive, costly, and require long-term antithrombotic therapy. The purpose of this study is to validate Seerlinq HeartCore, a novel CE-certified, non-invasive system that enables remote LVFP monitoring using photoplethysmography (PPG) and machine learning-based signal analysis.

Detailed description

Heart failure (HF) affects approximately 1-2% of the adult population in developed countries, with prevalence exceeding 10% among individuals older than 70 years. Despite advancements in diagnostics and treatment guided by evidence-based medicine, HF remains associated with high morbidity and mortality; up to 17% of patients die and up to 44% require hospitalization within 12 months. Monitoring of left ventricular filling pressure (LVFP) has been shown to improve survival, quality of life, and reduce hospitalization rates in patients with HF. However, existing methods for LVFP assessment are invasive, costly, and require long-term antithrombotic therapy, limiting their widespread application. The purpose of this study is to validate HeartCore, a novel CE-certified, non-invasive system that enables remote LVFP monitoring using photoplethysmography (PPG) combined with machine learning-based signal analysis. This will be a prospective, multicenter study enrolling three patient cohorts: RHC cohort, ECHO cohort, and RPM cohort. Participants will undergo 120-second PPG recordings in both upright and supine positions using a standard pulse oximeter connected to a smartphone. The PPG signals will be transmitted to a secure server and processed by the HeartCore algorithm to estimate LVFP, expressed as the diastolic reserve index (DRI), where a higher DRI indicates lower LVFP. The primary outcomes of the study will be: * The discrimination performance of the PPG-based HeartCore system for detecting elevated LVFP in the RHC and ECHO cohorts, measured by receiver operating characteristic area under the curve (ROC AUC), sensitivity, and specificity. * The change in DRI following furosemide up-titration in the RPM cohort. The secondary outcome will be: • The correlation between DRI and pulmonary capillary wedge pressure (PCWP) in the RHC cohort. This study aims to demonstrate that a non-invasive, widely available, and scalable PPG-based system can provide reliable assessment of LVFP in HF patients, potentially improving the management and outcomes of this population.

Conditions

• Heart Failure
• Photoplethysmography
• Right Heart Catheterization

Interventions

Type	Name	Description
PROCEDURE	PPG measurement	PPG signal will be measured on CE certified medical devices. Two measurements will be performed - standing and in the recumbent position using reflectance and transmitance method on finger and in ear canal. The each measurement will be 120s long. Detailed analysis of PPG signal and pathophysiological phenomena associated with HF - peripheral volume changes detectable in PPG signal - will help to understand better and clarify the pathophysiological mechanisms of peripheral volume changes in a failing heart.

Timeline

• Start date: 2023-03-01
• Primary completion: 2023-12-01
• Completion: 2024-12-01
• First posted: 2024-10-18
• Last updated: 2025-11-20

Locations

1 site across 1 country: Slovakia