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Clinical Trials/NCT01420484
NCT01420484
Completed
Not Applicable

Noninvasive Blood Pressure Measuring

Heidelberg University1 site in 1 country50 target enrollmentJanuary 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Transfemoral Implantation of Aortic Valves
Sponsor
Heidelberg University
Enrollment
50
Locations
1
Primary Endpoint
blood pressure
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

The role of continuous non-invasive arterial pressure (CNAP) in high risk patients with pronounced variation of arterial pressure will be assessed under analgosedation.

Therefore, patients will be analyzed during normo-, hypo- and hypertension with standard IAP undergoing elective transfemoral aortic valve implantation procedures. Systolic, diastolic, and mean invasive arterial pressures (IAP) will be compared to those obtained by CNAP. Data will be analysed in different periods of arterial pressure for agreement of the two methods and for determination of precision (i.e. measurement error) and accuracy (i.e. systematic error). Additionally, we will compare both methods regarding the amplitude and time of very fast changes in arterial pressure during intervals of functional cardiac arrests (rapid pacing).

Registry
clinicaltrials.gov
Start Date
January 2010
End Date
December 2013
Last Updated
12 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Konstanze Plaschke

PhD

Heidelberg University

Eligibility Criteria

Inclusion Criteria

  • Patients admitted for elective transfemoral implantation of the aortic valve in analgosedation will be included.
  • The patients' primary diagnosis was severe aortic stenosis, that was defined as a valve area of \<1cm² or a mean pressure gradient \>50mmHg.

Exclusion Criteria

  • an advanced dysfunction of peripheral perfusion (i.e. pronounced arterial peripheral artery occlusive disease or Raynaud's syndrome)
  • arterio-venous shunts for haemodialysis, and vascular surgery of the upper extremities

Outcomes

Primary Outcomes

blood pressure

Time Frame: blood pressure

Secondary Outcomes

  • age(age)

Study Sites (1)

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