Restore EF Observational Study
- Conditions
- NSTEMI - Non-ST Segment Elevation MIUnstable AnginaCoronary Artery DiseaseAngina, Stable
- Interventions
- Device: Prophylactic Impella support for a non-emergent PCI
- Registration Number
- NCT04648306
- Lead Sponsor
- Abiomed Inc.
- Brief Summary
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).
- Detailed Description
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)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 406
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Impella cohort Prophylactic Impella support for a non-emergent PCI Single arm study of patients who underwent non-emergent percutaneous coronary intervention with prophylactic Impella support
- Primary Outcome Measures
Name Time Method Left ventricular ejection fraction (LVEF) 90 days post Protective PCI (60 to 180 days window) Left ventricular ejection fraction (LVEF) %
- Secondary Outcome Measures
Name Time Method Survival Rate 90 days post Protected PCI (60 to 180 days window) Survival rate post non-emergent percutaneous coronary intervention (ProPCI)
Readmission 90 days post Protected PCI (60 to 180 days window) Readmission post non-emergent percutaneous coronary intervention (ProPCI)
NYHA Functional Class 90 days post Protected PCI (60 to 180 days window) New York Heart Association (NYHA) functional class
Trial Locations
- Locations (21)
St. Joseph's Medical Center
🇺🇸Phoenix, Arizona, United States
Washington Regional Medical Center
🇺🇸Fayetteville, Arkansas, United States
Northwest Medical Center
🇺🇸Springdale, Arkansas, United States
Tucson Medical Center
🇺🇸Tucson, Arizona, United States
UCSD Medical Center
🇺🇸San Diego, California, United States
Arkansas Cardiology P.A.
🇺🇸North Little Rock, Arkansas, United States
Loma Linda University Medical
🇺🇸Loma Linda, 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
Sentara Healthcare
🇺🇸Norfolk, Virginia, United States
Kingwood Medical Center
🇺🇸Kingwood, Texas, United States