Seerlinq: a Non-invasive System for Remote Monitoring of Left Ventricular Filling Pressure in Heart Failure Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 131
- 试验地点
- 1
- 主要终点
- Discrimination performance for elevated LVFP, measured by ROC AUC, sensitivity, and specificity in the ECHO studies.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females aged ≥ 18 years
- •Able to understand, and willing to provide written ICF
- •Stated willingness to comply with all study procedures
- •Confirmed diagnosis of heart failure according to the 2021 ESC guidelines
排除标准
- •Pregnancy or female participant lactating
- •Advanced renal failure (glomerular filtration rate <25 ml/min or need for renal replacement therapy),
- •Active malignancy requiring chemotherapy or radiotherapy
- •Complex congenital heart disease
- •Ventricular assist device support
- •Pulmonary hypertension classified as WHO group 1 or groups 3-
- •Other possible unforeseen medical conditions that the investigator deems unsafe for study participation
结局指标
主要结局
Discrimination performance for elevated LVFP, measured by ROC AUC, sensitivity, and specificity in the ECHO studies.
时间窗: in 1 year
The ability to distinguish elevated left ventricular filling pressure (LVFP) will be assessed using receiver operating characteristic area under the curve (ROC AUC), sensitivity, and specificity metrics in echocardiogram (ECHO) studies. This evaluation aims to validate the diagnostic accuracy of the proposed method.
Discrimination performance for elevated LVFP, measured by ROC AUC, sensitivity, and specificity in the RHC studies.
时间窗: in 1 year
The ability to distinguish elevated left ventricular filling pressure (LVFP) will be assessed using receiver operating characteristic area under the curve (ROC AUC), sensitivity, and specificity metrics in right heart catheterization (RHC) studies. This evaluation aims to validate the diagnostic accuracy of the proposed method.
LVFP changes post-diuretic up-titration in the remote monitoring analysis, evaluating its role in monitoring treatment response.
时间窗: in 1 year
Changes in left ventricular filling pressure (LVFP) following diuretic up-titration will be analyzed through remote monitoring to assess its effectiveness in tracking treatment response. The change in LVFP (DRI) pre- and post-treatment adjustment will be compared using appropriate statistical method. This endpoint will explore the utility of continuous monitoring in optimizing heart failure management.
次要结局
- The correlation between LVFP determined by PPG analysis by the Seerlinq HeartCore and LVFP (PCWP) measured during RHC.(in 1 year)