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NCT04465201
The Smart Pump Study
NA trial testing Impella CP with Smart Assist (Circulatory Support System) in Cardiac Output in 35 participants. Participants enrolled and being followed up; not accepting new ones.
31 December 2022
Quick facts
| Lead sponsor | Abiomed Inc. |
|---|---|
| Phase | NA |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 35 |
| Start date | 2 November 2020 |
| Primary completion | 31 December 2022 |
| Estimated completion | 31 December 2022 |
| Sites | 6 locations across United States |
Drugs / interventions tested
- Impella CP with Smart Assist (Circulatory Support System)
Conditions studied
- Cardiac Output — all drugs for Cardiac Output →
Sponsor
Abiomed Inc. — full company profile →
Who can join
18 and older, any sex, with Cardiac Output. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
To demonstrate that the Impella® Hemodynamic Platform (the "Study Device") is safe, and measurements obtained are as good as currently used methods. These measurements include how much pressure the heart is generating and how much blood your heart is pumping during the PCI.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04465201
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Cardiac Output
Currently open trials in the same condition.
- NCT07082283 — Short-Term Atrial Pacing and Hemodynamics After Cardiac Surgery · NA · recruiting
- NCT06551168 — Heat Acclimation in Females · NA · recruiting
- NCT06879769 — Optimization of Patient Preparation and Imaging Techniques for Cardiac CT · NA · 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
- NCT06964685 — Assessment of Support With Impella® Best Practices in Acute Myocardial Infarction Complicated by Cardiogenic Shock · recruiting
- NCT06308055 — Abiomed Impella RT-DAQ - Observational Study · active not recruiting
- NCT06637644 — Impella RP Flex with Smart Assist · recruiting
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 NCT04465201 (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: 24 October 2022
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/NCT04465201.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing