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).

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). - PLUTO-II

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON51694

Enrollment

157

Registered

2022-01-28

Start date

2022-11-21

Completion date

Unknown

Last updated

2026-06-15

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

Conditions

Valvular dysfunction valvular insufficiency Valvular heart disease

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: - Age

Design outcomes

Primary

Measure	Time frame
The main study endpoints comprise the differences in cardiac mechanoenergetics in individual patients, measurements before the intervention will be compared to measurements obtained immediate following the structural heart intervention in all cohorts. Cardiac mechanoenergetics are reflected by the parameters stroke work (SW, mmHg ml-1) and potential energy (PE, mmHg ml-1), together forming the pressure volume area (PVA, mmHg ml-1). SW, PE and PVA are obtained using real-time PVL measurements. Study parameters will be investigated for both ventricles, irrespective of study cohort.	—

Measure

Time frame

The main study endpoints comprise the differences in cardiac mechanoenergetics in individual patients, measurements before the intervention will be compared to measurements obtained immediate following the structural heart intervention in all cohorts. Cardiac mechanoenergetics are reflected by the parameters stroke work (SW, mmHg ml-1) and potential energy (PE, mmHg ml-1), together forming the pressure volume area (PVA, mmHg ml-1). SW, PE and PVA are obtained using real-time PVL measurements. Study parameters will be investigated for both ventricles, irrespective of study cohort.

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Secondary

Measure	Time frame
Secondary endpoints of the study are differences in the following parameters, all derived from PVL plots and subsequent calculations. According to the primary endpoints, measurements before the intervention will be compared to measurements obtained immediate following the structural heart intervention. All parameters will be investigated for both the left and right ventricle, irrespective of study cohort. The following parameters will be investigated: • Stroke volume (SV, mL). • Preload recruitable stroke work (PRSW in mmHg ml-1, calculated as SW / EDV) (reflecting myocardial contractility, largely independent of heart size). • Tau (reflecting lusitropy in ms). • Intraventricular dyssynchrony (in % on a systolic as well as diastolic level). • dP/dt (reflecting the maximal and minimal intraventricular pressure changes in mmHg s-1 as dP/dt max and dP/dt min). • End-systolic elastance (Ees) and effective arterial elastance (Ea), both in mmHg -1 with Ees/Ea indicating ventricular-arterial coupling. • End-diastolic volume (EDV, mL). • End-diastolic pressure (EDP, mmHg). • End-diastolic pressure-volume relation (EDPVR, mmHg mL-1). • EDV / dP/dt max (reflecting the myocardial contractile state). • End-systolic volume (ESV, mL). • End-systolic pressure (ESP, mmHg). • End-systolic pressure-volume relation (ESPVR, mmHg mL-1). • Starling contractile index (SCI, dP/dt max / EDV) (the preload adjusted contractility index in mmHg s-1 ml-1). • SW / PVA ratio (an index of ventricular function and efficiency from perspective of cardiomechanics). • V0 (mL, ventricular volume at 0 mmHg) (for the correct interpretation of ESPVR). • V15 (mL, ventricular volume at 15 mmHg) (as a guide for RV contractility). • V30 (mL, ventricular volume at 30 mmHg (reflecting ventricular compliance). • V100 (mL, ventricular volume at 100 mmHg (reflecting LV contractility). • Ventricular stiffness constant β (ml-1). The following parameters will also be obtained at the	—

Measure

Time frame

Secondary endpoints of the study are differences in the following parameters, all derived from PVL plots and subsequent calculations. According to the primary endpoints, measurements before the intervention will be compared to measurements obtained immediate following the structural heart intervention. All parameters will be investigated for both the left and right ventricle, irrespective of study cohort. The following parameters will be investigated: • Stroke volume (SV, mL). • Preload recruitable stroke work (PRSW in mmHg ml-1, calculated as SW / EDV) (reflecting myocardial contractility, largely independent of heart size). • Tau (reflecting lusitropy in ms). • Intraventricular dyssynchrony (in % on a systolic as well as diastolic level). • dP/dt (reflecting the maximal and minimal intraventricular pressure changes in mmHg s-1 as dP/dt max and dP/dt min). • End-systolic elastance (Ees) and effective arterial elastance (Ea), both in mmHg -1 with Ees/Ea indicating ventricular-arterial coupling. • End-diastolic volume (EDV, mL). • End-diastolic pressure (EDP, mmHg). • End-diastolic pressure-volume relation (EDPVR, mmHg mL-1). • EDV / dP/dt max (reflecting the myocardial contractile state). • End-systolic volume (ESV, mL). • End-systolic pressure (ESP, mmHg). • End-systolic pressure-volume relation (ESPVR, mmHg mL-1). • Starling contractile index (SCI, dP/dt max / EDV) (the preload adjusted contractility index in mmHg s-1 ml-1). • SW / PVA ratio (an index of ventricular function and efficiency from perspective of cardiomechanics). • V0 (mL, ventricular volume at 0 mmHg) (for the correct interpretation of ESPVR). • V15 (mL, ventricular volume at 15 mmHg) (as a guide for RV contractility). • V30 (mL, ventricular volume at 30 mmHg (reflecting ventricular compliance). • V100 (mL, ventricular volume at 100 mmHg (reflecting LV contractility). • Ventricular stiffness constant β (ml-1). The following parameters will also be obtained at the

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Countries

Netherlands

Contacts

Public ContactJ. Daemen

Erasmus MC, Universitair Medisch Centrum Rotterdam

j.daemen@erasmusmc.nl010-7032300

Outcome results