CompletedNot Applicable

Seerlinq: Non-invasive LVFP Monitoring in HF

Slovakia131 participantsStarted 2023-03-01

Plain-language 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.

Who can participate

Age range18 Years – 100 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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 3-5. * Other possible unforeseen medical conditions that the investigator deems unsafe for study participation

What they're measuring

Discrimination performance for elevated LVFP, measured by ROC AUC, sensitivity, and specificity in the ECHO studies.

Timeframe: in 1 year

Discrimination performance for elevated LVFP, measured by ROC AUC, sensitivity, and specificity in the RHC studies.

Timeframe: in 1 year

LVFP changes post-diuretic up-titration in the remote monitoring analysis, evaluating its role in monitoring treatment response.

Timeframe: in 1 year

Trial details

NCT IDNCT06649435

SponsorSeerlinq s. r. o.

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-12-01

View on ClinicalTrials.gov More Heart Failure trials

Plain-language summary

Who can participate

Age range18 Years – 100 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Discrimination performance for elevated LVFP, measured by ROC AUC, sensitivity, and specificity in the ECHO studies.

Timeframe: in 1 year

Discrimination performance for elevated LVFP, measured by ROC AUC, sensitivity, and specificity in the RHC studies.

Timeframe: in 1 year

LVFP changes post-diuretic up-titration in the remote monitoring analysis, evaluating its role in monitoring treatment response.

Timeframe: in 1 year