Restore EF Observational Study

Completed

Conditions studied: Coronary Artery Disease, Unstable Angina, Angina, Stable, NSTEMI - Non-ST Segment Elevation MI

In brief

A multi-center, prospective, observational, non-interventional single arm, study of the intermediate-term clinical outcomes collected from electronic health records of high-risk patients which have previously undergone standard of care prophylactic Impella support for a non-emergent percutaneous coronary intervention (PCI).

Key facts

Study ID

NCT04648306

Run by

Abiomed Inc.

People needed

406

Starts

2019-09-01

Expected to finish

2021-09-30

Last updated by the study team

2021-12-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years
• Subject has previously undergone (≥ 60 days) an Impella Protected PCI (ProPCI) at a study site as identified in the Impella quality (IQ) assurance database (patients who expired or were lost to follow-up prior to opening of the follow-up study window (day 60 post Impella protected PCI) will not be included in the study

You may not qualify if…

• Subject with cardiogenic shock at the time of Impella insertion. Cardiogenic shock defined as: systemic hypotension (systolic blood pressure (SBP) <90 mmHg or the need for inotropes/pressors to maintain a SBP >90mmHg)
• Subject with ST elevation myocardial infarction at the time of Impella insertion.
• Subject underwent coronary bypass surgery after the index Impella ProPCI
• Subject underwent repeat revascularization with PCI after the index Impella ProPCI
• Subject underwent other cardiac procedures including valve therapies (surgical or percutaneous) after the index Impella ProPCI
• Subject underwent cardiac resynchronization therapy (CRT) initiated after the index Impella ProPCI
• Any known medical condition with a life expectancy <6 months

Where it is running

• St. Joseph's Medical Center — Phoenix, Arizona, United States
• Tucson Medical Center — Tucson, Arizona, United States
• Washington Regional Medical Center — Fayetteville, Arkansas, United States
• Arkansas Cardiology P.A. — North Little Rock, Arkansas, United States
• Northwest Medical Center — Springdale, Arkansas, United States
• Loma Linda University Medical — Loma Linda, California, United States
• UCSD Medical Center — San Diego, California, United States
• Advent Health — Daytona Beach, Florida, United States
• NorthShore University HealthSystem — Skokie, Illinois, United States
• Genesis Medical Center — Davenport, Iowa, United States
• Baptist Healthcare System — Lexington, Kentucky, United States
• Lafayette General Medical Center — Houma, Louisiana, United States
• Mercy Hospital — Coon Rapids, Minnesota, United States
• St. Cloud Hospital — Saint Cloud, Minnesota, United States
• NYU Langone Medical Center — New York, New York, United States
• Vidant Medical Center — Greenville, North Carolina, United States
• Christ Hospital — Cincinnati, Ohio, United States
• Providence Portland Medical Center — Portland, Oregon, United States
• Presbyterian Hospital Dallas — Arlington, Texas, United States
• Kingwood Medical Center — Kingwood, Texas, United States
• Sentara Healthcare — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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