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NCT06645990: ELLIPSE1
Early Left Ventricular unLoading by Impella vs Intra-aortic Balloon Pump
trial testing Impella in Cardiogenic Shock in 500 participants. Currently enrolling.
1 January 2023
Quick facts
| Lead sponsor | University Hospital, Montpellier |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 500 |
| Start date | 1 January 2010 |
| Primary completion | 1 January 2023 |
| Estimated completion | 30 January 2025 |
| Sites | 1 location across France |
Drugs / interventions tested
- Impella
- IABP
Conditions studied
- Cardiogenic Shock — all drugs for Cardiogenic Shock →
Sponsor
University Hospital, Montpellier
Who can join
18 and older, any sex, with Cardiogenic Shock. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Over the past decade, VA-ECMO has become the main mechanical support for cardiogenic shock (CS) unresponsive to medical therapy. However, recent studies failed to show any significant survival benefit at 30 days compared to medical treatment for myocardial infarction-related CS. This could be due to the complications of VA-ECMO, such as LV overload and increased LV distension, which can hinder heart recovery. To address this, early LV unloading using devices like IABP or Impella (ECMELLA) may help by reducing LV wall stress and oxygen consumption. However, these techniques carry risks, and their benefit is still unclear. A randomized trial is needed to compare these approaches, but observational studies are also contributing to understanding the best strategies
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06645990
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Impella
Trials testing the same drug.
- NCT07001332 — ELEVATE High-Risk PCI Pivotal Study · NA · recruiting
- NCT06964685 — Assessment of Support With Impella® Best Practices in Acute Myocardial Infarction Complicated by Cardiogenic Shock · recruiting
- NCT05577195 — Left Ventricular Unloading to Improve Outcome in Cardiogenic Shock Patients on VA-ECMO · NA · unknown
Other recruiting trials for Cardiogenic Shock
Currently open trials in the same condition.
- NCT07527156 — Prolonged Nasogastric Administration of Ketones in Decompensated Heart Failure · Phase 4 · recruiting
- NCT07345559 — Personalisation of Mean Arterial Pressure in Adult Patients With Cardiogenic Shock · NA · recruiting
- NCT07374289 — On Scene ECPR in Ostrava · NA · recruiting
- NCT07402018 — Intra-aortic Balloon Counterpulsation (IABC) Compliance · recruiting
- NCT07309029 — Pre-Emptive LAVA-ECMO for Complex High-Risk TAVR · recruiting
Other University Hospital, Montpellier trials
Trials by the same sponsor.
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- NCT07534189 — Prospective Cohort Study Evaluating a Thermal Spa Programme in Symptomatic Knee Osteoarthritis · NA · not yet recruiting
- NCT07515638 — Immun4Cure Cohort of Autoimmune Diseases · not yet recruiting
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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 NCT06645990 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital, Montpellier
- Last refreshed: 17 October 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/NCT06645990.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing