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Restore EF Observational Study

NCT04648306 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 406

Last updated 2021-12-14

No results posted yet for this study

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).

Conditions

Interventions

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.

Sponsors & Collaborators

  • Abiomed Inc.

    lead INDUSTRY

Principal Investigators

  • Thom Dahle, MD · Saint Cloud Hospital

  • Jason Wollmuth, MD · Providence Health & Services

  • Lynn Morris, MD · East Carolina University

  • Craig Thompson, MD · NYU Langone

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2021-05-31
Completion
2021-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04648306 on ClinicalTrials.gov