Restore EF Observational Study

• Sponsor: Abiomed Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04648306
• Collaborator: (none)
• Enrollment: 406
• Locations: 21
• Actual Duration (Months): 25
• Patients Per Site: 19.3
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease; Unstable Angina; Angina, Stable; NSTEMI - Non-ST Segment Elevation MI	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.

1. Sample Size: The study will enroll more than 1,000 patients at up to 30 investigational sites with experienced Impella operators (≥ 25 cases).

2. Primary Endpoint: Subject's LVEF at 90 days post-ProPCI (60 to 180 days window) collected from the subject's EHR.

3. 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 Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 406 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Restore EF Observational Study (in High-risk PCI)
• Actual Study Start Date: Sep 1, 2019
• Actual Primary Completion Date: May 31, 2021
• Actual Study Completion Date: Sep 30, 2021

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Left ventricular ejection fraction (LVEF) [90 days post Protective PCI (60 to 180 days window)]

   Left ventricular ejection fraction (LVEF) %

Secondary Outcome Measures

1. Survival Rate [90 days post Protected PCI (60 to 180 days window)]

   Survival rate post non-emergent percutaneous coronary intervention (ProPCI)

2. NYHA Functional Class [90 days post Protected PCI (60 to 180 days window)]

   New York Heart Association (NYHA) functional class

3. Readmission [90 days post Protected PCI (60 to 180 days window)]

   Readmission post non-emergent percutaneous coronary intervention (ProPCI)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St. Joseph's Medical Center	Phoenix	Arizona	United States	85016
2	Tucson Medical Center	Tucson	Arizona	United States	85719
3	Washington Regional Medical Center	Fayetteville	Arkansas	United States	72703
4	Arkansas Cardiology P.A.	North Little Rock	Arkansas	United States	72117
5	Northwest Medical Center	Springdale	Arkansas	United States	72764
6	Loma Linda University Medical	Loma Linda	California	United States	92354
7	UCSD Medical Center	San Diego	California	United States	92093
8	Advent Health	Daytona Beach	Florida	United States	32117
9	NorthShore University HealthSystem	Skokie	Illinois	United States	60076
10	Genesis Medical Center	Davenport	Iowa	United States	52803
11	Baptist Healthcare System	Lexington	Kentucky	United States	40503
12	Lafayette General Medical Center	Houma	Louisiana	United States	70360
13	Mercy Hospital	Coon Rapids	Minnesota	United States	55433
14	St. Cloud Hospital	Saint Cloud	Minnesota	United States	56303
15	NYU Langone Medical Center	New York	New York	United States	10016
16	Vidant Medical Center	Greenville	North Carolina	United States	28275
17	Christ Hospital	Cincinnati	Ohio	United States	45219
18	Providence Portland Medical Center	Portland	Oregon	United States	97213
19	Presbyterian Hospital Dallas	Arlington	Texas	United States	76011
20	Kingwood Medical Center	Kingwood	Texas	United States	77339
21	Sentara Healthcare	Norfolk	Virginia	United States	23507

Sponsors and Collaborators

• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abiomed Inc.
• ClinicalTrials.gov Identifier: NCT04648306
• Other Study ID Numbers: V1-07012019
• First Posted: Dec 1, 2020
• Last Update Posted: Dec 14, 2021
• Last Verified: Dec 1, 2020

• 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
• Keywords provided by Abiomed Inc.: Impella; Hemodynamic Mechanical Support; Left ventricular ejection fraction; Surgical turndown; High Risk PCI
• Additional relevant MeSH terms: Coronary Artery Disease; Angina Pectoris; Angina, Unstable; Angina, Stable

Study Results

No Results Posted as of Dec 14, 2021