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NCT06964685: OASIS-AMICS
Assessment of Support With Impella® Best Practices in Acute Myocardial Infarction Complicated by Cardiogenic Shock
trial testing Impella in AMI Cardiogenic Shock in 350 participants. Currently enrolling.
30 September 2027
Quick facts
| Lead sponsor | Abiomed Inc. |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 350 |
| Start date | 10 July 2025 |
| Primary completion | 30 September 2027 |
| Estimated completion | 30 October 2028 |
| Sites | 10 locations across United States |
Drugs / interventions tested
- Impella
Conditions studied
- AMI Cardiogenic Shock — all drugs for AMI Cardiogenic Shock →
Sponsor
Abiomed Inc. — full company profile →
Who can join
18 and older, any sex, with AMI Cardiogenic Shock. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The observational study titled "Observational Assessment of Support with Impella Best Practices in Acute Myocardial Infarction Complicated by Cardiogenic Shock (OASIS-AMICS)" aims to evaluate the safety outcomes of patients with acute myocardial infarction complicated by cardiogenic shock (AMICS) who receive Impella CP during percutaneous coronary intervention (PCI) and who are managed with Impella best practices while receiving guideline-directed standard of care. This prospective, multicenter study will enroll up to 350 hemodynamically unstable patients with cardiogenic shock of less than 12 hours duration and acute myocardial infarction (AMI) of less than 24 hours duration. Cardiogenic shock will be confirmed by tissue hypoperfusion (lactate ≥ 2.5mmol/L and/or SvO2 \<55% with a normal PaO2) and systolic blood pressure \<100 mmHg and/or need for vasopressor therapy (dopamine/norepinepherine or epinephrine). Patients will be assessed for various safety endpoints, including a composite safety endpoint involving major bleeding, acute limb ischemia, and acute kidney injury. Secondary endpoints will evaluate all-cause mortality, major adverse cardiovascular and cerebrovascular events (MACCE), and hospitalizations through 1-year post-Impella implant. All patients presenting with AMICS at study sites will be screened for inclusion in the study after hospital discharge (or after death, if prior to hospital discharge). IRB approved consent waiver will be used to collect data from electronic health records from; Impella placement to discharge and post-discharge at 30 days post-Impella implant, 6 months post-Impella implant, and 1 year post-Impella implant.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06964685
- 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
- NCT05577195 — Left Ventricular Unloading to Improve Outcome in Cardiogenic Shock Patients on VA-ECMO · NA · unknown
- NCT06645990 — Early Left Ventricular unLoading by Impella vs Intra-aortic Balloon Pump · recruiting
Other Abiomed Inc. trials
Trials by the same sponsor.
- NCT06965504 — INitiation and Titration of Guideline Directed Medical TheRApy in HearT Failure Cardiogenic Shock With ImpElla 5.5 for C · NA · not yet recruiting
- NCT06765226 — Impella Pump Return Study to Analyze Deposits and Biomaterial in Used Pumps · recruiting
- NCT06308055 — Abiomed Impella RT-DAQ - Observational Study · active not recruiting
- NCT06637644 — Impella RP Flex with Smart Assist · recruiting
- NCT05506449 — The RECOVER IV Trial · NA · terminated
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 NCT06964685 (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 Abiomed Inc.
- Last refreshed: 20 March 2026
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/NCT06964685.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing