Status:
RECRUITING
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)
Lead Sponsor:
Erasmus Medical Center
Conditions:
Heart Failure
Valvular Heart Disease
Eligibility:
All Genders
18+ years
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 ...
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 o...
Eligibility Criteria
Inclusion
- \- Adult patients undergoing elective Transcatheter Aortic Valve Implantation (TAVI) or Transcatheter Edge-to-Edge repair (TEER).
Exclusion
- 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.
Key Trial Info
Start Date :
November 14 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 14 2025
Estimated Enrollment :
157 Patients enrolled
Trial Details
Trial ID
NCT06204783
Start Date
November 14 2022
End Date
May 14 2025
Last Update
January 12 2024
Active Locations (1)
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1
Erasmus Medical Center
Rotterdam, South Holland, Netherlands, 3015GD