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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06204783
Other study ID # PLUTO-II
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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