Heart FailurePLUTO-IINCT06204783
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)
An observational study of Heart Failure and Valvular Heart Disease, run by Erasmus Medical Center at 1 site in Netherlands.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Valvular Heart Disease, Aortic Stenosis
- What is being tested?
- Pressure volume (PV) loop measurement
- How many people
- 157 participants
- Where
- 1 siteNetherlands
- Study dates
- 14 Nov 2022to 14 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing elective TAVI or mitral TEER.
Who may be able to join
- Adult patients undergoing elective Transcatheter Aortic Valve Implantation (TAVI) or Transcatheter Edge-to-Edge repair (TEER).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus Medical Center
Rotterdam, South Holland, 3015GD
Antoon JM van den Enden, +31 70 308896, a.vandenenden@erasmusmc.nl
Nicolas M Van Mieghem, Prof MD PhD
About this study
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.
Read the 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.
- Conditions
- Heart Failure, Valvular Heart Disease, Aortic Stenosis, Mitral Insufficiency, Tricuspid Insufficiency
- Being tested
- Pressure volume (PV) loop measurement
- Keywords
- Pressure-volume loop, Cardiac mechanoenergetics
- Medical subject headings
- Heart Failure, Heart Valve Diseases, Aortic Valve Stenosis, Mitral Valve Insufficiency, Tricuspid Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pressure volume (PV) loop measurementOther
Pressure volume (PV) loop measurement using a conductance catheter
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: Transaortic Valve Implantation (TAVI) | Elective TAVI with biventricular PV loop monitoring (throughout the procedure) Receives: 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) Receives: 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) Receives: Other: Pressure volume (PV) loop measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac mechanoenergetics
The change in cardiac mechanoenergetics (stroke work, potential energy and pressure-volume area in mmHg/mL) induced by the particular procedure
Measured: Periprocedural time window
Secondary outcomes (15)
Stroke volume (mL)
Based on perprocedural conductance catheter measurements
Measured: Periprocedural change (directly before vs. after the procedure)
Preload recruitable stroke work (mmHg/mL)
Based on perprocedural conductance catheter measurements
Measured: Periprocedural change (directly before vs. after the procedure)
Tau (ms)
Based on perprocedural conductance catheter measurements
Measured: Periprocedural change (directly before vs. after the procedure)
Intraventricular dyssynchrony (%)
Based on perprocedural conductance catheter measurements
Measured: Periprocedural change (directly before vs. after the procedure)
dP/dt min and dP/dt max (mmHg/sec)
Based on perprocedural conductance catheter measurements
Measured: Periprocedural change (directly before vs. after the procedure)
End-systolic elastance (Ees) and arterial elastance (Ea) (mmHg/mL)
With Ees/Ea ratio reflecting ventricular-vascular coupling
Measured: Periprocedural change (directly before vs. after the procedure)
End-systolic and end-diastolic volume (mL)
Based on perprocedural conductance catheter measurements
Measured: Periprocedural change (directly before vs. after the procedure)
End-systolic and end-diastolic pressure (mmHg)
Based on perprocedural conductance catheter measurements
Measured: Periprocedural change (directly before vs. after the procedure)
Starling Contractile Index (mmHg/mL)
Based on perprocedural conductance catheter measurements
Measured: Periprocedural change (directly before vs. after the procedure)
V0, V15, V30 and V100 mmHg (mL)
Based on perprocedural conductance catheter measurements
Measured: Periprocedural change (directly before vs. after the procedure)
SW/PVA ratio (based on the primary outcome)
Based on perprocedural conductance catheter measurements
Measured: Periprocedural change (directly before vs. after the procedure)
Beta (ventricular stiffness constant, unitless)
Based on perprocedural conductance catheter measurements
Measured: Periprocedural change (directly before vs. after the procedure)
Mortality
All-cause
Measured: 30-day follow-up
Hospital stay
in days
Measured: 30-day follow-up
Postprocedural morbidity (%)
including acute kidney failure, cardiac decompensation and unexpected need for vasopressor or inotropic support (all yes/no)
Measured: 30-day follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start14 Nov 2022
- Primary completion14 May 2024 (estimated)
- Study completion14 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 157 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicolas van Mieghem, Erasmus Medical Center
- Investigators
- Nicolas M Van Mieghem, Prof MD PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06204783
- Sponsor's protocol ID
- PLUTO-II
- Acronym
- PLUTO-II
- Status last verified
- Jan 2024
- First submitted
- 13 Feb 2023
- Last updated
- 12 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41241186
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06204783
- Acronym / sponsor ID
- PLUTO-II / PLUTO-II
- Conditions
- Heart Failure, Valvular Heart Disease, Aortic Stenosis, Mitral Insufficiency, Tricuspid Insufficiency
- Keywords
- Pressure-volume loop, Cardiac mechanoenergetics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 157 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 14 Nov 2022 (actual)
- Primary completion
- 14 May 2024 (estimated)
- Study completion
- 14 May 2025 (estimated)
- First posted
- 12 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort A: Transaortic Valve Implantation (TAVI) | – | Other: Pressure volume (PV) loop measurementElective TAVI with biventricular PV loop monitoring (throughout the procedure) |
| Cohort B: Mitral Transcatheter Edge-to-Edge Repair (mitral TEER) | – | Other: Pressure volume (PV) loop measurementElective mitral TEER with biventricular PV loop monitoring (throughout the procedure) |
| Cohort C: Tricuspid Transcatheter Edge-to-Edge Repair (tricuspid TEER) | – | Other: Pressure volume (PV) loop measurementElective tricuspid TEER with biventricular PV loop monitoring (throughout the procedure) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing elective TAVI or mitral TEER.
Key inclusion criteria (1 listed)
- Adult patients undergoing elective Transcatheter Aortic Valve Implantation (TAVI) or Transcatheter Edge-to-Edge repair (TEER).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pressure volume (PV) loop measurementPressure volume (PV) loop measurement using a conductance catheter | Other | 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) |
Primary outcome
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
15 secondary outcomes
Stroke volume (mL)
Time frame: Periprocedural change (directly before vs. after the procedure)
Preload recruitable stroke work (mmHg/mL)
Time frame: Periprocedural change (directly before vs. after the procedure)
Tau (ms)
Time frame: Periprocedural change (directly before vs. after the procedure)
Intraventricular dyssynchrony (%)
Time frame: 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)
End-systolic elastance (Ees) and arterial elastance (Ea) (mmHg/mL)
Time frame: 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)
End-systolic and end-diastolic pressure (mmHg)
Time frame: Periprocedural change (directly before vs. after the procedure)
Starling Contractile Index (mmHg/mL)
Time frame: 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)
SW/PVA ratio (based on the primary outcome)
Time frame: Periprocedural change (directly before vs. after the procedure)
Beta (ventricular stiffness constant, unitless)
Time frame: Periprocedural change (directly before vs. after the procedure)
Mortality
Time frame: 30-day follow-up
Hospital stay
Time frame: 30-day follow-up
Postprocedural morbidity (%)
Time frame: 30-day follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
- Derived from this study: PubMed 41241186van 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolas M Van Mieghem, Prof MD PhD principal investigator
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Valvular Heart Disease, run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antoon JM van den Enden, MD (+31 10 7038896, a.vandenenden@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac mechanoenergetics (time frame: Periprocedural time window). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06204783, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2024.