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Waveform Analysis for Vascular Evaluation and Cardiovascular Advancements in Research and Enhancement

Waveform Analysis for Vascular Evaluation and Cardiovascular Advancements in Research and Enhancement - WAVECARE study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON56849
Enrollment
900
Registered
2023-06-22
Start date
2024-06-12
Completion date
Unknown
Last updated
2026-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

valvular heart diseases and aneurysms (or dilation of a blood vessel) heart valve abnormalities and aneurysms (or vessel dilation)

Interventions

ClearSight fingercuff and EV1000Samsung smart watchHappitech smartphone applicatie

Sponsors

Amsterdam UMC
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - >18 years of age - informed consent - diagnosed with valvular heart disease,  thoracic aortic aneurysm or heart failure for surgerical procedure or outpatient visit appointment - or scheduled for coronary artery bypass grafting with good left ventricular function.

Exclusion criteria

Exclusion criteria: Subjects of which the non-invasive blood pressure cannot be measured with the finger cuff according to the Instruction for Use of the CS/EV1000 system

Design outcomes

Primary

MeasureTime frame
The primary endpoint of the study is to assess whether the non-invasive arterial pressure waveform measured at the finger level exhibits any distinctive morphological characteristics. In particular, analysis will be focused on the following characteristics: · Prolongation of the total duration of ejection: systolic phase of the reconstructed aortic pressure waveform · Prolongation of the systolic upstroke time· The slope of the pressure rise during systole: dP/dt · The presence and position of the anacrotic and dicrotic notches · Alterations of the shape of the pulse contour · Increase of time-constant of the diastolic phase of the waveform · The presence of the high-frequency components in the reconstructed aortic pressure waveform · Reduction in pulse pressure

Secondary

MeasureTime frame
- Differences in accuracy of the model between males and females - Differences in the accuracy of the model related to the cause of thoracic aortic aneurysm such as genetic or age related- To detect the existence of valvular heart disease based on the accessible and low cost photoplethysmogram (PPG) signal.

Countries

Netherlands

Contacts

Public ContactD.P. Veelo

Amsterdam UMC

d.p.veelo@amsterdamumc.nl020 566 6478

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Apr 3, 2026