Restore EF Observational Study

NCT04648306 | Completed FDA Device

• 1 other identifier: V1-07012019
• Study Type: observational
• Target: 406
• Locations: 1 country
• Sites: 21

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).

Conditions

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

Keywords

Impella; Hemodynamic Mechanical Support; Left ventricular ejection fraction; Surgical turndown; High Risk PCI

Outcome Measures

Primary Outcomes (1)

• Left ventricular ejection fraction (LVEF)

  Left ventricular ejection fraction (LVEF) %

  90 days post Protective PCI (60 to 180 days window)

Secondary Outcomes (3)

• Survival Rate

  90 days post Protected PCI (60 to 180 days window)

• NYHA Functional Class

  90 days post Protected PCI (60 to 180 days window)

• Readmission

  90 days post Protected PCI (60 to 180 days window)

Study Arms (1)

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

Interventions

Prophylactic Impella support for a non-emergent PCI DEVICE

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.

Impella cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abiomed Inc.: lead

Study Sites (21)

St. Joseph's Medical Center

Phoenix, Arizona, 85016, United States

Location

Tucson Medical Center

Tucson, Arizona, 85719, United States

Location

Washington Regional Medical Center

Fayetteville, Arkansas, 72703, United States

Location

Arkansas Cardiology P.A.

North Little Rock, Arkansas, 72117, United States

Location

Northwest Medical Center

Springdale, Arkansas, 72764, United States

Location

Loma Linda University Medical

Loma Linda, California, 92354, United States

Location

UCSD Medical Center

San Diego, California, 92093, United States

Location

Advent Health

Daytona Beach, Florida, 32117, United States

Location

NorthShore University HealthSystem

Skokie, Illinois, 60076, United States

Location

Genesis Medical Center

Davenport, Iowa, 52803, United States

Location

Baptist Healthcare System

Lexington, Kentucky, 40503, United States

Location

Lafayette General Medical Center

Houma, Louisiana, 70360, United States

Location

Mercy Hospital

Coon Rapids, Minnesota, 55433, United States

Location

St. Cloud Hospital

Saint Cloud, Minnesota, 56303, United States

Location

NYU Langone Medical Center

New York, New York, 10016, United States

Location

Vidant Medical Center

Greenville, North Carolina, 28275, United States

Location

Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

Presbyterian Hospital Dallas

Arlington, Texas, 76011, United States

Location

Kingwood Medical Center

Kingwood, Texas, 77339, United States

Location

Sentara Healthcare

Norfolk, Virginia, 23507, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease; Angina, Unstable; Angina, Stable; Non-ST Elevated Myocardial Infarction

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Necrosis

Study Officials

• Thom Dahle, MD

  Saint Cloud Hospital

  STUDY CHAIR

• Jason Wollmuth, MD

  Providence Health & Services

  STUDY CHAIR

• Lynn Morris, MD

  East Carolina University

  STUDY CHAIR

• Craig Thompson, MD

  NYU Langone

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 90 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2020
• First Posted: December 1, 2020
• Study Start: September 1, 2019
• Primary Completion: May 31, 2021
• Study Completion: September 30, 2021
• Last Updated: December 14, 2021

Record last verified: 2020-12

Locations

US (21)