Restore EF Observational Study

Coronary Artery Disease Clinical Trial

Official title: Restore EF Observational Study (in High-risk PCI)

Status Completed

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).

Clinical Trial 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) ;

Related Conditions & MeSH terms

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

• NCT number: NCT04648306
• Study type: Observational [Patient Registry]
• Source: Abiomed Inc.
• Status: Completed
• Start date: September 1, 2019
• Completion date: September 30, 2021