Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
406 participants
OBSERVATIONAL
2019-09-01
2021-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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)
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Impella cohort
Single arm study of patients who underwent non-emergent percutaneous coronary intervention with prophylactic Impella support
Prophylactic Impella support for a non-emergent PCI
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Prophylactic Impella support for a non-emergent PCI
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 Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Abiomed Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Thom Dahle, MD
Role: STUDY_CHAIR
Saint Cloud Hospital
Jason Wollmuth, MD
Role: STUDY_CHAIR
Providence Health & Services
Lynn Morris, MD
Role: STUDY_CHAIR
East Carolina University
Craig Thompson, MD
Role: STUDY_CHAIR
NYU Langone
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
V1-07012019
Identifier Type: -
Identifier Source: org_study_id