Restore EF Observational Study

Abiomed

Status: Completed

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

Treatments: Device: Prophylactic Impella support for a non-emergent PCI

Study type: Observational

Funder types: Industry

Identifiers

NCT04648306

V1-07012019

Details and patient eligibility

About

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).

Full 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)

Enrollment: 406 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

406 participants in 1 patient group

Impella cohort

Description:

Single arm study of patients who underwent non-emergent percutaneous coronary intervention with prophylactic Impella support

Treatment:

Device: Prophylactic Impella support for a non-emergent PCI