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) (PLUTO-II)

January 3, 2024 updated by: Nicolas van Mieghem, Erasmus Medical Center
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
157

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Netherlands
    • Zuid-Holland
      • Rotterdam, Zuid-Holland, Netherlands, 3015GD
        • Recruiting
        • Erasmus Medical Center
        • Principal Investigator:
          • Nicolas M Van Mieghem, Prof MD PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Adult patients undergoing elective TAVI or mitral TEER.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Cohort A: Transaortic Valve Implantation (TAVI)
Elective TAVI with biventricular PV loop monitoring (throughout the procedure)
Other: Pressure volume (PV) loop measurement
Pressure volume (PV) loop measurement using a conductance catheter
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
Pressure volume (PV) loop measurement using a conductance catheter
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
Pressure volume (PV) loop measurement using a conductance catheter

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cardiac mechanoenergetics
Time Frame: Periprocedural time window
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Stroke volume (mL)
Time Frame: Periprocedural change (directly before vs. after the procedure)
Based on perprocedural conductance catheter measurements
Periprocedural change (directly before vs. after the procedure)
Preload recruitable stroke work (mmHg/mL)
Time Frame: Periprocedural change (directly before vs. after the procedure)
Based on perprocedural conductance catheter measurements
Periprocedural change (directly before vs. after the procedure)
Tau (ms)
Time Frame: Periprocedural change (directly before vs. after the procedure)
Based on perprocedural conductance catheter measurements
Periprocedural change (directly before vs. after the procedure)
Intraventricular dyssynchrony (%)
Time Frame: Periprocedural change (directly before vs. after the procedure)
Based on perprocedural conductance catheter measurements
Periprocedural change (directly before vs. after the procedure)
dP/dt min and dP/dt max (mmHg/sec)
Time Frame: Periprocedural change (directly before vs. after the procedure)
Based on perprocedural conductance catheter measurements
Periprocedural change (directly before vs. after the procedure)
End-systolic elastance (Ees) and arterial elastance (Ea) (mmHg/mL)
Time Frame: Periprocedural change (directly before vs. after the procedure)
With Ees/Ea ratio reflecting ventricular-vascular coupling
Periprocedural change (directly before vs. after the procedure)
End-systolic and end-diastolic volume (mL)
Time Frame: Periprocedural change (directly before vs. after the procedure)
Based on perprocedural conductance catheter measurements
Periprocedural change (directly before vs. after the procedure)
End-systolic and end-diastolic pressure (mmHg)
Time Frame: Periprocedural change (directly before vs. after the procedure)
Based on perprocedural conductance catheter measurements
Periprocedural change (directly before vs. after the procedure)
Starling Contractile Index (mmHg/mL)
Time Frame: Periprocedural change (directly before vs. after the procedure)
Based on perprocedural conductance catheter measurements
Periprocedural change (directly before vs. after the procedure)
V0, V15, V30 and V100 mmHg (mL)
Time Frame: Periprocedural change (directly before vs. after the procedure)
Based on perprocedural conductance catheter measurements
Periprocedural change (directly before vs. after the procedure)
SW/PVA ratio (based on the primary outcome)
Time Frame: Periprocedural change (directly before vs. after the procedure)
Based on perprocedural conductance catheter measurements
Periprocedural change (directly before vs. after the procedure)
Beta (ventricular stiffness constant, unitless)
Time Frame: Periprocedural change (directly before vs. after the procedure)
Based on perprocedural conductance catheter measurements
Periprocedural change (directly before vs. after the procedure)
Mortality
Time Frame: 30-day follow-up
All-cause
30-day follow-up
Hospital stay
Time Frame: 30-day follow-up
in days
30-day follow-up
Postprocedural morbidity (%)
Time Frame: 30-day follow-up
including acute kidney failure, cardiac decompensation and unexpected need for vasopressor or inotropic support (all yes/no)
30-day follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Erasmus Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nicolas M Van Mieghem, Prof MD PhD, Erasmus Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 14, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 14, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 14, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 13, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 3, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 12, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 12, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 3, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PLUTO-II

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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