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)

Last updated: January 3, 2024
Sponsor: Erasmus Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Disease

Chest Pain

Mitral Valve Regurgitation

Treatment

Pressure volume (PV) loop measurement

Clinical Study ID

NCT06204783
PLUTO-II
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 157
Treatment Group(s): 1
Primary Treatment: Pressure volume (PV) loop measurement
Phase:
Study Start date:
November 14, 2022
Estimated Completion Date:
May 14, 2025

Study 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.

Connect with a study center

  • Erasmus Medical Center

    Rotterdam, Zuid-Holland 3015GD
    Netherlands

    Active - Recruiting

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