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)

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Erasmus University

Status

Enrolling

Conditions

Tricuspid Insufficiency
Valvular Heart Disease
Mitral Insufficiency
Heart Failure
Aortic Stenosis

Treatments

Other: Pressure volume (PV) loop measurement

Study type

Observational

Funder types

Other

Identifiers

NCT06204783
PLUTO-II

Details and patient eligibility

About

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.

Full 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.

Enrollment

157 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

157 participants in 3 patient groups

Cohort A: Transaortic Valve Implantation (TAVI)
Description:
Elective TAVI with biventricular PV loop monitoring (throughout the procedure)
Treatment:
Other: Pressure volume (PV) loop measurement
Cohort B: Mitral Transcatheter Edge-to-Edge Repair (mitral TEER)
Description:
Elective mitral TEER with biventricular PV loop monitoring (throughout the procedure)
Treatment:
Other: Pressure volume (PV) loop measurement
Cohort C: Tricuspid Transcatheter Edge-to-Edge Repair (tricuspid TEER)
Description:
Elective tricuspid TEER with biventricular PV loop monitoring (throughout the procedure)
Treatment:
Other: Pressure volume (PV) loop measurement

Trial contacts and locations

1

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Central trial contact

Antoon JM van den Enden, MD

Data sourced from clinicaltrials.gov

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