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)

Heart Failure Clinical Trial

— 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06204783
• Other study ID #: PLUTO-II
• Status: Recruiting
• Start date: November 14, 2022
• Est. completion date: May 14, 2025

Study information

• Verified date: January 2024
• Source: Erasmus Medical Center
• Contact: Antoon JM van den Enden, MD
• Phone: +31 10 7038896
• Email: a.vandenenden[@]erasmusmc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 157
• Est. completion date: May 14, 2025
• Est. primary completion date: May 14, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Heart Diseases
• Heart Failure
• Heart Valve Diseases
• Mitral Insufficiency
• Mitral Valve Insufficiency
• Tricuspid Insufficiency
• Tricuspid Valve Insufficiency
• Valvular Heart Disease

Intervention

Other:
• Pressure volume (PV) loop measurement
Pressure volume (PV) loop measurement using a conductance catheter

Locations

Country	Name	City	State
Netherlands	Erasmus Medical Center	Rotterdam	Zuid-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac mechanoenergetics	The change in cardiac mechanoenergetics (stroke work, potential energy and pressure-volume area in mmHg/mL) induced by the particular procedure	Periprocedural time window
Secondary	Stroke volume (mL)	Based on perprocedural conductance catheter measurements	Periprocedural change (directly before vs. after the procedure)
Secondary	Preload recruitable stroke work (mmHg/mL)	Based on perprocedural conductance catheter measurements	Periprocedural change (directly before vs. after the procedure)
Secondary	Tau (ms)	Based on perprocedural conductance catheter measurements	Periprocedural change (directly before vs. after the procedure)
Secondary	Intraventricular dyssynchrony (%)	Based on perprocedural conductance catheter measurements	Periprocedural change (directly before vs. after the procedure)
Secondary	dP/dt min and dP/dt max (mmHg/sec)	Based on perprocedural conductance catheter measurements	Periprocedural change (directly before vs. after the procedure)
Secondary	End-systolic elastance (Ees) and arterial elastance (Ea) (mmHg/mL)	With Ees/Ea ratio reflecting ventricular-vascular coupling	Periprocedural change (directly before vs. after the procedure)
Secondary	End-systolic and end-diastolic volume (mL)	Based on perprocedural conductance catheter measurements	Periprocedural change (directly before vs. after the procedure)
Secondary	End-systolic and end-diastolic pressure (mmHg)	Based on perprocedural conductance catheter measurements	Periprocedural change (directly before vs. after the procedure)
Secondary	Starling Contractile Index (mmHg/mL)	Based on perprocedural conductance catheter measurements	Periprocedural change (directly before vs. after the procedure)
Secondary	V0, V15, V30 and V100 mmHg (mL)	Based on perprocedural conductance catheter measurements	Periprocedural change (directly before vs. after the procedure)
Secondary	SW/PVA ratio (based on the primary outcome)	Based on perprocedural conductance catheter measurements	Periprocedural change (directly before vs. after the procedure)
Secondary	Beta (ventricular stiffness constant, unitless)	Based on perprocedural conductance catheter measurements	Periprocedural change (directly before vs. after the procedure)
Secondary	Mortality	All-cause	30-day follow-up
Secondary	Hospital stay	in days	30-day follow-up
Secondary	Postprocedural morbidity (%)	including acute kidney failure, cardiac decompensation and unexpected need for vasopressor or inotropic support (all yes/no)	30-day follow-up