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Completed

NCT Number: NCT04648306

Restore EF Observational Study

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).

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Key information

Conditions

Coronary Artery Disease Angina Pectoris Angina, Stable Angina, Unstable Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Chest Pain Coronary Disease Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia NSTEMI - Non-ST Segment Elevation MI Necrosis Neurologic Manifestations Non-ST Elevated Myocardial Infarction Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Unstable Angina Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Joseph's Medical Center, Phoenix, Arizona, United States

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About this study

  • 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
  • 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.

  • Sample Size: The study will enroll more than 1,000 patients at up to 30 investigational sites with experienced Impella operators (≥ 25 cases).
  • Primary Endpoint: Subject's LVEF at 90 days post-ProPCI (60 to 180 days window) collected from the subject's EHR.
  • 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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prophylactic Impella support for a non-emergent PCI

Device

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.

Primary outcomes

  1. Left ventricular ejection fraction (LVEF)

    Time frame: 90 days post Protective PCI (60 to 180 days window)

    Left ventricular ejection fraction (LVEF) %

Secondary outcomes

  1. Survival Rate

    Time frame: 90 days post Protected PCI (60 to 180 days window)

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

  2. NYHA Functional Class

    Time frame: 90 days post Protected PCI (60 to 180 days window)

    New York Heart Association (NYHA) functional class

  3. Readmission

    Time frame: 90 days post Protected PCI (60 to 180 days window)

    Readmission post non-emergent percutaneous coronary intervention (ProPCI)

Sponsors and collaborators

Lead sponsor

Abiomed Inc.

Industry

Registry information

Official study title

Restore EF Observational Study (in High-risk PCI)

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Dec 1, 2020
Registry last updated
Dec 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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