Feasibility of Continuous Noninvasive Finger Arterial Blood Pressure Measurement for Detection and Staging of Aortic Stenosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-01

Study Completion Date

2018-12-31

Brief Summary

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The primary purpose of this study is electronic data collection of arterial pressure waveform signals in patients with Aortic Stenosis. The collected digital pressure waveform data will be used to assess the feasibility of using the arterial pressure signal as a decision support tool for early detection of aortic stenosis conditions. Furthermore we evaluate hemodynamic parameters before and after valve repair and its correlation with outcome.

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Detailed Description

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Conditions

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Aortic Stenosis, Calcific

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients for TAVR

Nexfin measuremtents

Intervention Type DEVICE

There will be only observational recordings, no interevntion

Interventions

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Nexfin measuremtents

There will be only observational recordings, no interevntion

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* o Patients with severe senile degenerative aortic valve stenosis

* Clinical team agrees on eligibility including assessment that TAVR is appropriate for the subject
* Patients undergoing TAVR via the femoral approach
* Patients who normally require a guiding catheter for central aortic pressure monitoring during the TAVR procedure
* Patient must be 18 years old or older
* Patient, or legally authorized representative, has given consent to be in the study
* Patient height and weight are available prior to study
* Ability to perform a Nexfin measurement at the left hand side.

Exclusion Criteria

* o Patients with contraindications for placement of aortic catheter

* Patients with mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation \>3+).
* Aortic valve is a congenital unicuspid or congenital bicuspid valve, or is noncalcified
* Patients being treated with an intra-aortic balloon pump
* Patients less than 40 kg in weight
* Female patients of childbearing potential with a known pregnancy
* Patient is currently participating in an investigational drug or another device study that clinically interferes with the study endpoints

Eligible Sex

ALL

Accepts Healthy Volunteers

No