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)
Launched by ERASMUS MEDICAL CENTER · Jan 3, 2024
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
The PLUTO-II clinical trial is studying how a special tool called biventricular pressure-volume (PV) loop monitoring can help doctors better understand how the heart works during certain procedures for heart conditions. Specifically, the trial looks at patients who are undergoing two types of treatments: Transcatheter Aortic Valve Implantation (TAVI) and Transcatheter Edge-to-Edge Repair (TEER). These treatments are used for serious heart issues like heart failure and valve diseases. By measuring changes in heart function before and after these procedures, researchers hope to improve how these interventions are performed in the future.
To participate in this trial, patients need to be adults who are scheduled for either TAVI or TEER. Unfortunately, individuals with certain heart conditions, such as congenital heart disease, or those using specific mechanical support devices during their procedure cannot take part. Participants will have their heart function monitored closely before and after their procedure, which may help tailor their treatment and improve outcomes. This trial is currently recruiting participants, and it is open to all adults aged 65 and older.
Gender
ALL
Eligibility 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.
About Erasmus Medical Center
Erasmus Medical Center, located in Rotterdam, Netherlands, is a leading academic medical center renowned for its commitment to advancing healthcare through innovative research and clinical trials. As a prominent institution within the Erasmus University Rotterdam, the center integrates cutting-edge scientific inquiry with comprehensive patient care, focusing on a wide range of medical specialties. With a strong emphasis on multidisciplinary collaboration, Erasmus Medical Center aims to translate research findings into tangible clinical applications, enhancing treatment options and improving patient outcomes. The institution is dedicated to conducting ethical and rigorous clinical trials that contribute to the global body of medical knowledge and foster advancements in personalized medicine.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Rotterdam, Zuid Holland, Netherlands
Patients applied
Trial Officials
Nicolas M Van Mieghem, Prof MD PhD
Principal Investigator
Erasmus Medical Center
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported