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Validation of the Schiller BR-102 Plus PWA Device to Measure Central and Peripheral Hemodynamics

Validation of the Schiller BR-102 Plus PWA Device to Measure Central and Peripheral Hemodynamics

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02596165
Acronym
BR-102
Enrollment
45
Registered
2015-11-04
Start date
2016-03-31
Completion date
2016-10-31
Last updated
2020-11-17

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

Conditions

Aortic Stiffness, Hypertension

Keywords

validation, pulse wave analysis, blood pressure monitoring

Brief summary

The significance of parameters of the central hemodynamic is based upon their strong association with left ventricular hypertrophy and target organ damage at the heart. Noninvasive, auscultatory/ oscillometric and therefore easy applicable measurements of the central hemodynamic such as presented by the Schiller BR-102 plus PWA device implicate highly promising potential for research and daily clinical praxis for improved cardiovascular risk assessment on the population level. The purpose of this study is to evaluate the validity of the central and peripheral blood pressure and central arterial stiffness measured with the device BR-102 plus PWA from Schiller (Schiller AG, Baar, Switzerland).

Detailed description

The proposed study is an open, monocentric cross-sectional research study for the evaluation of the validity of the central and peripheral blood pressure and central arterial stiffness measured with the device BR-102 plus PWA from Schiller (Schiller AG, Baar, Switzerland). For that purpose measurement of the respective parameters in cardiovascular disease free individuals will be compared with validated devices and the agreement between the devices will be statistically analyzed. Central blood pressure and central arterial stiffness are clinically increasingly meaningful parameters of the cardiovascular system that allow improved, early cardiovascular risk stratification. The significance of parameters of the central hemodynamic is based upon their strong association with left ventricular hypertrophy and target organ damage at the heart. Noninvasive, auscultatory/ oscillometric and therefore easy applicable measurements of the central hemodynamic such as presented by the Schiller BR-102 plus PWA device implicate highly promising potential for research and daily clinical praxis for improved cardiovascular risk assessment on the population level.

Interventions

DEVICEPulse wave analysis measurement with Schiller BR-102 Plus PWA device

Measurement of central and peripheral blood pressure and central arterial stiffness simultaneously with the Schiller BR-102 Plus PWA device

Sponsors

Kantonsspital Liestal
CollaboratorOTHER
University of Basel
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Healthy individuals free of clinically relevant cardiovascular diseases or diabetes based on medical history and physical examination. * Heart rhythm: Sinus rhythm * Blood pressure range: 10 to 12 subjects in each of the three systolic blood pressure (SBP) and three diastolic blood pressure (DBP) recruitment ranges (low, medium, high).

Exclusion criteria

* Cardiac arrhythmia (atrial fibrillation, frequent extrasystoles) * Pacemaker-dependent * Pregnancy after the 6th month of the pregnancy * Body mass index (BMI)\>30 kg/m2 * Known significant carotid or femoral artery stenosis * Impalpable arterial pulse at site of measurement * Age under 18 years.

Design outcomes

Primary

MeasureTime frameDescription
central blood pressure1 dayMeasurement of central blood pressure and central arterial stiffness simultaneously with the Schiller BR-102 Plus PWA device
central arterial stiffness1 dayMeasurement of central blood pressure and central arterial stiffness simultaneously with the Schiller BR-102 Plus PWA device

Secondary

MeasureTime frameDescription
peripheral blood pressure1 dayMeasurement peripheral blood pressure with the Schiller BR-102 Plus PWA device

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026