Restore EF Observational Study

Abiomed Inc.406 enrolled

Overview

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).

1. Hypothesis The prophylactic use of Impella 2.5 or CP heart pumps during a non-emergent PCI in hemodynamically stable patients at high-risk for periprocedural complications during the procedure is associated with a significant improvement in the patient's LVEF and clinical status (heart failure symptoms and hospital readmissions) in the intermediate-term follow-up period post-ProPCI 2. Objectives The primary objective of this study is to assess the patient's LVEF at 90 days post-ProPCI (60 to 180 days window) as assessed in routine clinical practice and collected from EHR by clinical investigators. The secondary objective of the study is to assess the potential association between the completeness of revascularization and the clinical status at 90 days post-ProPCI (60-180 days window). Clinical status includes NYHA heart failure functional class and hospital readmission. 3. Sample Size: The study will enroll more than 1,000 patients at up to 30 investigational sites with experienced Impella operators (≥ 25 cases). 4. Primary Endpoint: Subject's LVEF at 90 days post-ProPCI (60 to 180 days window) collected from the subject's EHR. 5. Secondary Endpoints: * Completeness and extent of revascularization * NYHA functional class at 90 days post-ProPCI (60 to 180 days window) * Readmission at 90 days post-ProPCI (60 to 180 days window)

Study Type

OBSERVATIONAL

Enrollment

406

Conditions

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

Interventions

Prophylactic Impella support for a non-emergent PCIDEVICE

Impella percutaneous mechanical circulatory support is placed via the femoral or axillary artery prior to a non-emergent PCI in patients at high risk for periprocedural complications including hemodynamic collapse.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Locations (21)

St. Joseph's Medical Center

Phoenix, Arizona, United States

Tucson Medical Center

Outcomes

Primary Outcomes

Left ventricular ejection fraction (LVEF)

Left ventricular ejection fraction (LVEF) %

Time frame: 90 days post Protective PCI (60 to 180 days window)

Secondary Outcomes

Survival Rate

Survival rate post non-emergent percutaneous coronary intervention (ProPCI)

Time frame: 90 days post Protected PCI (60 to 180 days window)

NYHA Functional Class

New York Heart Association (NYHA) functional class

Time frame: 90 days post Protected PCI (60 to 180 days window)

Readmission

Readmission post non-emergent percutaneous coronary intervention (ProPCI)

Time frame: 90 days post Protected PCI (60 to 180 days window)

Data from ClinicalTrials.gov

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