Clinical trial NCT06204783: 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)
Official title: 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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure
Valvular Heart Disease
Aortic Stenosis
Mitral Insufficiency
Tricuspid Insufficiency
Keywords: Pressure-volume loop
Cardiac mechanoenergetics
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2024-01-12
Enrollment: 157
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients undergoing elective TAVI or mitral TEER.

Brief summary: The aim of PLUTO-II is to use biventricular pressure-volume (PV) loop measurements to improve the understanding of direct changes in cardiac and hemodynamic physiology induced by transcatheter aortic valve implantation (TAVI) or tricuspid edge-to-edge repair (TEER). These procedures evoke immediate changes in cardiac mechanoenergetics, ventricular-vascular interaction as well as ventricular (in)dependency. Within the context of PLUTO-II, patients will undergo biventricular PV-loop measurements before and after TAVI or TEER. In future, the application of perprocedural PV loop monitoring may tailor the daily individual decision making process during structural interventions in the catheterization laboratory.

Detailed description: Pressure-Volume (PV) loop monitoring is a tool allowing direct visualization of individual cardiac and hemodynamic physiology, including parameters reflecting cardiac mechanoenergetics (a derivative of the myocardial metabolic demand) as well as the ventricular-arterial coupling. The concepts of changing biventricular cardiac and hemodynamic physiology induced by structural heart interventions, including Transcatheter Aortic Valve Implantation (TAVI), Transcatheter Edge-to-Edge Mitral Repair (mitral TEER) and Transcatheter Edge-to-Edge Tricuspid Repair (tricuspid TEER) are largely based on hypotheses, computer simulations and non-invasive (echocardiographic) estimations. PVL monitoring has the potential to identify unique characteristics of TAVI, mitral TEER and tricuspid TEER from the perspective of changing baseline cardiovascular physiology, including (a change in) interference between both ventricles (i.e. the ventricular crosstalk). Perprocedural (biventricular) PV loop monitoring can be of direct clinical relevance by appreciating the ventricular tolerance of increased cardiac afterload induced by the particular intervention in individual patients. In future, real-time PV loop analysis can be adjunctive to the individual decision-making process during routine structural interventions.

Eligibility criteria: Inclusion Criteria:

- Adult patients undergoing elective Transcatheter Aortic Valve Implantation (TAVI) or Transcatheter Edge-to-Edge repair (TEER).

Exclusion Criteria:

* Confirmed or suspected (concomitant) congenital heart disease.
* Mechanical circulatory support (including Impella, PulseCath, Intra-Aortic Balloon Counterpulsation or Extracorporeal Membrane Oxygenation) was used during the procedure aiming to improve native cardiac output.
* No (written) informed consent was obtained.

Primary outcomes:
measure: Cardiac mechanoenergetics
timeFrame: Periprocedural time window
Secondary outcomes:
measure: Stroke volume (mL)
timeFrame: Periprocedural change (directly before vs. after the procedure)
measure: Preload recruitable stroke work (mmHg/mL)
timeFrame: Periprocedural change (directly before vs. after the procedure)
measure: Tau (ms)
timeFrame: Periprocedural change (directly before vs. after the procedure)
measure: Intraventricular dyssynchrony (%)
timeFrame: Periprocedural change (directly before vs. after the procedure)
measure: dP/dt min and dP/dt max (mmHg/sec)
timeFrame: Periprocedural change (directly before vs. after the procedure)
measure: End-systolic elastance (Ees) and arterial elastance (Ea) (mmHg/mL)
timeFrame: Periprocedural change (directly before vs. after the procedure)
measure: End-systolic and end-diastolic volume (mL)
timeFrame: Periprocedural change (directly before vs. after the procedure)
measure: End-systolic and end-diastolic pressure (mmHg)
timeFrame: Periprocedural change (directly before vs. after the procedure)
measure: Starling Contractile Index (mmHg/mL)
timeFrame: Periprocedural change (directly before vs. after the procedure)
measure: V0, V15, V30 and V100 mmHg (mL)
timeFrame: Periprocedural change (directly before vs. after the procedure)
measure: SW/PVA ratio (based on the primary outcome)
timeFrame: Periprocedural change (directly before vs. after the procedure)
measure: Beta (ventricular stiffness constant, unitless)
timeFrame: Periprocedural change (directly before vs. after the procedure)
measure: Mortality
timeFrame: 30-day follow-up
measure: Hospital stay
timeFrame: 30-day follow-up
measure: Postprocedural morbidity (%)
timeFrame: 30-day follow-up
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
state: Zuid-Holland
Study officials:
affiliation: Erasmus Medical Center
name: Nicolas M Van Mieghem, Prof MD PhD
role: PRINCIPAL_INVESTIGATOR
References: