Evaluation of Mitral Valve Insufficiency Under General Anesthesia

Recruiting

• Conditions: Mitral Valve Insufficiency; Mitral Regurgitation; Mitral Valve Disease

• Registration Number: NCT05736289
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-09
• Study Start: 2023-02-13
• Study First Submitted QC: 2023-02-17
• Study First Posted: 2023-02-21
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-21
• Last Update Posted: 2023-07-24
• Primary Completion: 2025-07-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Arterial pressure waveform changes	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.

Trial Locations

Locations (1)

Amsterdam University Medical Center; 🇳🇱 Amsterdam, Netherlands