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
Location: See location...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

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

Locations
Other Locations
Netherlands
Erasmus Medical Center
RECRUITING
Rotterdam
Contact Information
Primary
Antoon JM van den Enden, MD
a.vandenenden@erasmusmc.nl
+31 10 7038896
Time Frame
Start Date: 2022-11-14
Estimated Completion Date: 2025-05-14
Participants
Target number of participants: 157
Treatments
Cohort A: Transaortic Valve Implantation (TAVI)
Elective TAVI with biventricular PV loop monitoring (throughout the procedure)
Cohort B: Mitral Transcatheter Edge-to-Edge Repair (mitral TEER)
Elective mitral TEER with biventricular PV loop monitoring (throughout the procedure)
Cohort C: Tricuspid Transcatheter Edge-to-Edge Repair (tricuspid TEER)
Elective tricuspid TEER with biventricular PV loop monitoring (throughout the procedure)
Sponsors
Leads: Erasmus Medical Center

This content was sourced from clinicaltrials.gov