Restore EF Observational Study

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).

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Angina, Stable; Unstable Angina; NSTEMI - Non-ST Segment Elevation MI
• Intervention / Treatment: Device: Prophylactic Impella support for a non-emergent 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)

• Study Type: Observational
• Enrollment (Actual): 406

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • St. Joseph's Medical Center
    • Tucson, Arizona, United States, 85719
      • Tucson Medical Center
  • Arkansas
    • Fayetteville, Arkansas, United States, 72703
      • Washington Regional Medical Center
    • North Little Rock, Arkansas, United States, 72117
      • Arkansas Cardiology P.A.
    • Springdale, Arkansas, United States, 72764
      • Northwest Medical Center
  • California
    • Loma Linda, California, United States, 92354
      • Loma Linda University Medical
    • San Diego, California, United States, 92093
      • UCSD Medical Center
  • Florida
    • Daytona Beach, Florida, United States, 32117
      • Advent Health
  • Illinois
    • Skokie, Illinois, United States, 60076
      • Northshore University Healthsystem
  • Iowa
    • Davenport, Iowa, United States, 52803
      • Genesis Medical Center
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • Baptist Healthcare System
  • Louisiana
    • Houma, Louisiana, United States, 70360
      • Lafayette General Medical Center
  • Minnesota
    • Coon Rapids, Minnesota, United States, 55433
      • Mercy Hospital
    • Saint Cloud, Minnesota, United States, 56303
      • St. Cloud Hospital
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Medical Center
  • North Carolina
    • Greenville, North Carolina, United States, 28275
      • Vidant Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Christ Hospital
  • Oregon
    • Portland, Oregon, United States, 97213
      • Providence Portland Medical Center
  • Texas
    • Arlington, Texas, United States, 76011
      • Presbyterian Hospital Dallas
    • Kingwood, Texas, United States, 77339
      • Kingwood Medical Center
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Sentara Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who meet all the inclusion criteria and none of the exclusion criteria will be enrolled in the study.

Patients in whom prophylactic hemodynamic support with Impella was used during a non-emergent PCI will be evaluated for study participation at 60 days post index PCI procedure with Impella. In this study the index procedure is designated as Impella Protected PCI (ProPCI). Patients with cardiogenic shock and/or ST elevation myocardial infarction (STEMI) at the time of Impella initiation will not be included in this study.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Impella cohort; Single arm study of patients who underwent non-emergent percutaneous coronary intervention with prophylactic Impella support	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Left ventricular ejection fraction (LVEF)	Left ventricular ejection fraction (LVEF) %	90 days post Protective PCI (60 to 180 days window)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival Rate	Survival rate post non-emergent percutaneous coronary intervention (ProPCI)	90 days post Protected PCI (60 to 180 days window)
NYHA Functional Class	New York Heart Association (NYHA) functional class	90 days post Protected PCI (60 to 180 days window)
Readmission	Readmission post non-emergent percutaneous coronary intervention (ProPCI)	90 days post Protected PCI (60 to 180 days window)

Collaborators and Investigators

• Sponsor: Abiomed Inc.
• Investigators: Study Chair: Thom Dahle, MD, Saint Cloud Hospital; Study Chair: Jason Wollmuth, MD, Providence Health & Services; Study Chair: Lynn Morris, MD, Vidant Medical Center; Study Chair: Craig Thompson, MD, NYU Langone

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Actual): May 31, 2021
• Study Completion (Actual): September 30, 2021

Study Registration Dates

• First Submitted: November 17, 2020
• First Submitted That Met QC Criteria: November 23, 2020
• First Posted (Actual): December 1, 2020

Study Record Updates

• Last Update Posted (Actual): December 14, 2021
• Last Update Submitted That Met QC Criteria: December 10, 2021
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Impella; Left ventricular ejection fraction; Hemodynamic Mechanical Support; Surgical turndown; High Risk PCI
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pain; Neurologic Manifestations; Coronary Disease; Chest Pain; Coronary Artery Disease; Angina Pectoris; Angina, Stable; Angina, Unstable
• Other Study ID Numbers: V1-07012019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes