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Clinical Trials/NCT05736289
NCT05736289
Recruiting
Not Applicable

Evaluation of Mitral Valve Insufficiency Under General Anesthesia

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)1 site in 1 country50 target enrollmentFebruary 13, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mitral Regurgitation
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Enrollment
50
Locations
1
Primary Endpoint
Arterial pressure waveform changes
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

Observational study in adult humans undergoing surgical or cardiological intervention for mitral valve insufficiency. Investigators aim to evaluate hemodynamic changes on an arterial pressure waveform level in patients before and after mitral valve intervention using Nexfin (BMEYE, Amsterdam, the Netherlands) continuous non-invasive hemodynamic monitoring, using finger cuff based technology to register beat-to-beat data

Registry
clinicaltrials.gov
Start Date
February 13, 2023
End Date
July 1, 2025
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Denise P. Veelo

Principal Investigator, Associate Professor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Eligibility Criteria

Inclusion Criteria

  • All patients with moderate or severe mitral valve insufficiency undergoing cardiothoracic surgery or percutaneous treatment for this condition
  • Adult patients (\>18 years)

Exclusion Criteria

  • No informed consent

Outcomes

Primary Outcomes

Arterial pressure waveform changes

Time Frame: Before and during general anesthesia for mitral valve repair or replacement, ranging from 1 to 5 hours.

Arterial pressure waveform as recorded by a continuous non invasive hemodynamic monitoring system.

Study Sites (1)

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