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NCT06204783: PLUTO-II
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)
trial testing Pressure volume (PV) loop measurement in Heart Failure in 157 participants. Status unknown.
14 May 2024
Quick facts
| Lead sponsor | Erasmus Medical Center |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 157 |
| Start date | 14 November 2022 |
| Primary completion | 14 May 2024 |
| Estimated completion | 14 May 2025 |
| Sites | 1 location across Netherlands |
Drugs / interventions tested
- Pressure volume (PV) loop measurement
Conditions studied
- Heart Failure — all drugs for Heart Failure →
- Valvular Heart Disease — all drugs for Valvular Heart Disease →
- Aortic Stenosis — all drugs for Aortic Stenosis →
- Mitral Insufficiency — all drugs for Mitral Insufficiency →
Sponsor
Erasmus Medical Center
Who can join
18 and older, any sex, with Heart Failure or Valvular Heart Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Changes in Biventricular Cardiac Mechanics After Transcatheter Edge-to-Edge Repair for Severe Tricuspid Regurgitation.
Mondellini GM, van den Enden AJM, van den Dorpel MMP, Ren CB, et al · · 2026 · PMID 41570794 · DOI 10.1016/j.jacadv.2025.102549 -
Immediate changes in left ventricular cardiac mechanics following transcatheter aortic valve replacement for severe aortic stenosis - an in-vivo pressure-volume analysis study.
van den Enden AJM, van den Dorpel MMP, Mondellini GM, Mattace-Raso AM, et al · · 2026 · PMID 41241186 · DOI 10.1016/j.ahj.2025.107302
Verify or expand the search:
- PubMed search for NCT06204783
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06204783 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Erasmus Medical Center
- Last refreshed: 12 January 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06204783.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing