Extended monitoring and success evaluation of percutaneous catheter-supported AV valve interventions using pulse contour analysis

Recruiting

• Conditions: I34.0; I07.1; Mitral (valve) insufficiency; Tricuspid insufficiency

• Registration Number: DRKS00031547
• Lead Sponsor: Klinik für Anästhesiologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-12
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Therapy of severe AV valve regurgitation by percutaneous catheter-based intervention.
- Capacity to consent

Exclusion Criteria

- Pre-existing circulatory disorders of the upper extremities
- Emergency intervention
- Cardiogenic shock
- Lack of informed consent for study participation

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determination of deltaHZV (the difference in stroke volume before and after intervention) using pulse contour analysis by the FloTrackTM system.

Secondary Outcome Measures

Name	Time	Method
- Comparison of FloTrackTM readings with peri-interventional transesophageal echocardiography readings (cardiac output).<br>- Comparison of change in central venous saturation before and after intervention.<br>- Assessment of microcirculation using hyperspectral imaging during and after intervention.<br>- Correlation between macrohemodynamic changes and microcirculation of the skin: tissue oxygenation (StO2), near-infrared perfusion index (NIR), tissue hemoglobin index (THI), and tissue water index (TWI).<br>- Longitudinal changes in organ function parameters such as creatinine and pro-BNP before and after intervention.