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NCT05736289 Clinical Trial

Evaluation of Mitral Valve Insufficiency Under General Anesthesia

Mitral Regurgitation Clinical Trial

— MITIGATE  

Official title:
Evaluation of Mitral Valve Insufficiency Under General Anesthesia

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05736289
Other study ID # W22_423
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 13, 2023
Est. completion date July 1, 2025

Study information
Verified date July 2023
Source Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Contact Johan TM Tol, MD
Phone 020 566 6478
Email j.tol2@amsterdamumc.nl
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date July 1, 2025
Est. primary completion date July 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Netherlands Amsterdam University Medical Center Amsterdam

Sponsors (1)
Lead Sponsor Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary Arterial pressure waveform changes Arterial pressure waveform as recorded by a continuous non invasive hemodynamic monitoring system. Before and during general anesthesia for mitral valve repair or replacement, ranging from 1 to 5 hours.
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