NCT04648306

Restore EF Observational Study

Restore EF Observational Study (in High-risk PCI)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 406 (actual)
• Sponsor: Abiomed Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

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)

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-09-01
• Primary completion: 2021-05-31
• Completion: 2021-09-30
• First posted: 2020-12-01
• Last updated: 2021-12-14

Locations

21 sites across 1 country: United States

Regulatory

• FDA-regulated device study