Restore EF Observational Study

Coronary Artery Disease Clinical Trial

Official title:

Restore EF Observational Study (in High-risk PCI)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04648306
• Other study ID #: V1-07012019
• Status: Completed
• Start date: September 1, 2019
• Est. completion date: September 30, 2021

Study information

• Verified date: December 2020
• Source: Abiomed Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 406
• Est. completion date: September 30, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	Presbyterian Hospital Dallas	Arlington	Texas
United States	Christ Hospital	Cincinnati	Ohio
United States	Mercy Hospital	Coon Rapids	Minnesota
United States	Genesis Medical Center	Davenport	Iowa
United States	Advent Health	Daytona Beach	Florida
United States	Washington Regional Medical Center	Fayetteville	Arkansas
United States	Vidant Medical Center	Greenville	North Carolina
United States	Lafayette General Medical Center	Houma	Louisiana
United States	Kingwood Medical Center	Kingwood	Texas
United States	Baptist Healthcare System	Lexington	Kentucky
United States	Loma Linda University Medical	Loma Linda	California
United States	NYU Langone Medical Center	New York	New York
United States	Sentara Healthcare	Norfolk	Virginia
United States	Arkansas Cardiology P.A.	North Little Rock	Arkansas
United States	St. Joseph's Medical Center	Phoenix	Arizona
United States	Providence Portland Medical Center	Portland	Oregon
United States	St. Cloud Hospital	Saint Cloud	Minnesota
United States	UCSD Medical Center	San Diego	California
United States	NorthShore University HealthSystem	Skokie	Illinois
United States	Northwest Medical Center	Springdale	Arkansas
United States	Tucson Medical Center	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Abiomed Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left ventricular ejection fraction (LVEF)	Left ventricular ejection fraction (LVEF) %	90 days post Protective PCI (60 to 180 days window)
Secondary	Survival Rate	Survival rate post non-emergent percutaneous coronary intervention (ProPCI)	90 days post Protected PCI (60 to 180 days window)
Secondary	NYHA Functional Class	New York Heart Association (NYHA) functional class	90 days post Protected PCI (60 to 180 days window)
Secondary	Readmission	Readmission post non-emergent percutaneous coronary intervention (ProPCI)	90 days post Protected PCI (60 to 180 days window)