Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06204783
Status:
RECRUITING
Last Update Posted:
2024-01-12
First Post:
2023-02-13
Brief 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
Sponsor:
Erasmus Medical Center
Organization:
Erasmus Medical Center
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PLUTO-II
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 independency 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 ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None