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 | Unknown

• 1 other identifier: PLUTO-II
• Study Type: observational
• Target: 157
• Locations: 1 country
• Sites: 1

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 (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

Keywords

Pressure-volume loop; Cardiac mechanoenergetics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• Stroke volume (mL)

  Periprocedural change (directly before vs. after the procedure)

• Preload recruitable stroke work (mmHg/mL)

  Periprocedural change (directly before vs. after the procedure)

• Tau (ms)

  Periprocedural change (directly before vs. after the procedure)

• Intraventricular dyssynchrony (%)

  Periprocedural change (directly before vs. after the procedure)

• dP/dt min and dP/dt max (mmHg/sec)

  Periprocedural change (directly before vs. after the procedure)

Study Arms (3)

Cohort A: Transaortic Valve Implantation (TAVI)

Elective TAVI with biventricular PV loop monitoring (throughout the procedure)

Other: Pressure volume (PV) loop measurement

Cohort B: Mitral Transcatheter Edge-to-Edge Repair (mitral TEER)

Elective mitral TEER with biventricular PV loop monitoring (throughout the procedure)

Other: Pressure volume (PV) loop measurement

Cohort C: Tricuspid Transcatheter Edge-to-Edge Repair (tricuspid TEER)

Elective tricuspid TEER with biventricular PV loop monitoring (throughout the procedure)

Other: Pressure volume (PV) loop measurement

Interventions

Pressure volume (PV) loop measurement OTHER

Pressure volume (PV) loop measurement using a conductance catheter

Cohort A: Transaortic Valve Implantation (TAVI); Cohort B: Mitral Transcatheter Edge-to-Edge Repair (mitral TEER); Cohort C: Tricuspid Transcatheter Edge-to-Edge Repair (tricuspid TEER)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients undergoing elective TAVI or mitral TEER.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus Medical Center

Rotterdam, South Holland, 3015GD, Netherlands

RECRUITING

Related Publications (1)

• van den Enden AJM, van den Dorpel MMP, Mondellini GM, Mattace-Raso AM, Adrichem R, Bastos MB, Schreuder JJ, Lenzen MJ, Kardys I, Geleijnse ML, Nuis RJ, Daemen J, Burkhoff D, Van Mieghem NM. Immediate changes in left ventricular cardiac mechanics following transcatheter aortic valve replacement for severe aortic stenosis - an in-vivo pressure-volume analysis study. Am Heart J. 2026 Mar;293:107302. doi: 10.1016/j.ahj.2025.107302. Epub 2025 Nov 14.

  PMID: 41241186 DERIVED

MeSH Terms

Conditions

Heart Failure; Heart Valve Diseases; Aortic Valve Stenosis; Mitral Valve Insufficiency; Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Ventricular Outflow Obstruction

Study Officials

• Nicolas M Van Mieghem, Prof MD PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antoon JM van den Enden, MD

CONTACT

+31 10 7038896; a.vandenenden@erasmusmc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof. dr. N.M. Van Mieghem

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: January 12, 2024
• Study Start: November 14, 2022
• Primary Completion: May 14, 2024
• Study Completion: May 14, 2025
• Last Updated: January 12, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)