MedTrace Logo

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)

NCT06204783 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 157

Last updated 2024-01-12

No results posted yet for this 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.

Conditions

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

Interventions

OTHER

Pressure volume (PV) loop measurement

Pressure volume (PV) loop measurement using a conductance catheter

Sponsors & Collaborators

Principal Investigators

  • Nicolas M Van Mieghem, Prof MD PhD · Erasmus Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-14
Primary Completion
2024-05-14
Completion
2025-05-14

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06204783 on ClinicalTrials.gov