Understanding complications and tolerance of Impella devices in cardiogenic shock
IMPELLA, Complications and Tolerance
This study looks at patients with cardiogenic shock who are using Impella devices to see what complications they might face and how safe the devices are.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 800 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Montpellier Academic / other |
| Locations | 1 site (Montpellier) |
| Trial ID | NCT06644963 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients experiencing cardiogenic shock due to myocardial infarction who are supported by Impella devices. It aims to assess the complications associated with these devices, particularly hemocompatibility-related adverse events such as bleeding and thrombosis. The study will analyze data from patients treated between 2010 and 2022 to better understand the risks and outcomes associated with Impella use. By examining these complications, the research seeks to improve clinical practices and patient safety.
Who should consider this trial
Good fit: Ideal candidates for this study are adult patients admitted for cardiogenic shock who are receiving support from Impella devices.
Not a fit: Patients who do not have an Impella device or are using the Impella 2.5 or Impella RP will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for patients with cardiogenic shock, reducing complications associated with Impella devices.
How similar studies have performed: While there have been studies on the use of Impella devices, this specific observational approach focusing on hemocompatibility-related complications is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients admitted for cardiogenic shock supported by Impella (5, 5.5 or CP) between January 1, 2010, and December 31, 2022 (as an isolated circulatory support or combined with others Temporary Mechanical Circulatory Support) Exclusion Criteria: * Absence of Impella * Impella 2.5 * Impella RP (right)
Where this trial is running
Montpellier
- Montpellier university hospital — Montpellier, France (Recruiting)
Study contacts
- Principal investigator: Aurore UGHETTO, MD — Montpellier University Hospital
- Study coordinator: Aurore UGHETTO, MD
- Email: a-ughetto@chu-montpellier.fr
- Phone: +33622054893
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.