Monitoring heart function during structural heart interventions
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)
This study is trying to see how heart function changes during two specific heart procedures, TAVI and TEER, to help doctors make better decisions while treating patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 157 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Erasmus Medical Center Academic / other |
| Locations | 1 site (Rotterdam, Zuid-Holland) |
| Trial ID | NCT06204783 on ClinicalTrials.gov |
What this trial studies
PLUTO-II aims to enhance understanding of cardiac and hemodynamic changes during transcatheter aortic valve implantation (TAVI) and tricuspid edge-to-edge repair (TEER) using biventricular pressure-volume loop measurements. This observational study will assess the immediate effects of these procedures on cardiac mechanoenergetics and ventricular-arterial interaction. By monitoring these parameters before and after the interventions, the study seeks to provide insights that could inform clinical decision-making in real-time during structural heart procedures.
Who should consider this trial
Good fit: Ideal candidates include adult patients scheduled for elective TAVI or TEER procedures.
Not a fit: Patients with confirmed or suspected congenital heart disease or those requiring mechanical circulatory support will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more personalized and effective treatment strategies for patients undergoing heart interventions.
How similar studies have performed: While the use of pressure-volume loop monitoring is established, this specific application in real-time during structural heart interventions is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Rotterdam, Zuid-Holland
- Erasmus Medical Center — Rotterdam, Zuid-Holland, Netherlands (Recruiting)
Study contacts
- Principal investigator: Nicolas M Van Mieghem, Prof MD PhD — Erasmus Medical Center
- Study coordinator: Antoon JM van den Enden, MD
- Email: a.vandenenden@erasmusmc.nl
- Phone: +31 10 7038896
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.