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Restore EF Observational Study (in High-risk PCI)
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)
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
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
Start Date
September 1, 2019
Primary Completion Date
May 31, 2021
Completion Date
September 30, 2021
Last Updated
December 14, 2021
406
ACTUAL participants
Prophylactic Impella support for a non-emergent PCI
DEVICE
Lead Sponsor
Abiomed Inc.
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07444957