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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00031547

Enrollment

Registered

2023-06-12

Start date

2023-06-09

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I34.0 I07.1

Interventions

Group 1: Minimally invasive percutaneous catheter-supported atrioventricular valve reconstruction with extended hemodynamic monitoring

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
- Comparison of FloTrackTM readings with peri-interventional transesophageal echocardiography readings (cardiac output). - Comparison of change in central venous saturation before and after intervention. - Assessment of microcirculation using hyperspectral imaging during and after intervention. - 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). - Longitudinal changes in organ function parameters such as creatinine and pro-BNP before and after intervention.	—

Measure

Time frame

- Comparison of FloTrackTM readings with peri-interventional transesophageal echocardiography readings (cardiac output). - Comparison of change in central venous saturation before and after intervention. - Assessment of microcirculation using hyperspectral imaging during and after intervention. - 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). - Longitudinal changes in organ function parameters such as creatinine and pro-BNP before and after intervention.

—

Countries

Germany

Contacts

Public ContactChristoph Lichtenstern

Klinik für Anästhesiologie

christoph.lichtenstern@med.uni-heidelberg.de+496221 5634627

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026