Real-time Pressure volume Loop monitoring as a guide for enhanced Understanding of changes in elemental cardiovascular physiology during Therapeutic strategies aiming for hemodynamic Optimization. Cohort II: Structural heart interventions (PLUTO-II).
- Conditions
- Valvular dysfunctionvalvular insufficiency1004697310007593
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 157
Inclusion Criteria
- Scheduled for TAVI.
- Scheduled for mitral TEER (Mitraclip).
- Scheduled for tricuspid TEER (Triclip).
Patients undergoing elective TAVI, mitral TEER or tricuspid TEER are eligible
for study participation irrespective of device specifications or device
manufacturer. Such technical details, (including valve size or brand), do not
preclude study eligibility.
Exclusion Criteria
- Age < 18 years.
- Confirmed or suspected (concomitant) congenital heart disease.
- Mechanical circulatory support (including Impella, PulseCath, Intra-Aortic
Balloon Counterpulsation or Extracorporeal Membrane Oxygenation) used during
the procedure aiming for improved cardiac output.
- No (written) informed consent was obtained.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study endpoints comprise the differences in cardiac mechanoenergetics<br /><br>in individual patients, measurements before the intervention will be compared<br /><br>to measurements obtained immediate following the structural heart intervention<br /><br>in all cohorts. Cardiac mechanoenergetics are reflected by the parameters<br /><br>stroke work (SW, mmHg ml-1) and potential energy (PE, mmHg ml-1), together<br /><br>forming the pressure volume area (PVA, mmHg ml-1). SW, PE and PVA are obtained<br /><br>using real-time PVL measurements. Study parameters will be investigated for<br /><br>both ventricles, irrespective of study cohort. </p><br>
- Secondary Outcome Measures
Name Time Method