Impella Supported OPCABG

NCT04339452 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2025-01-27

No results posted yet for this study

Summary

The present study introduces a novel approach to coronary revascularization through the use of a short term minimally-invasive left ventricular assist device (LVAD) to minimize myocardial injury and eliminate low output state during the perioperative period

Conditions

  • Ischemic Cardiomyopathy

Interventions

DEVICE

Impella 5.5 with SmartAssist Supported OPCABG

Subjects will undergo insertion of an axillary or ascending aortic Impella 5.5 with SmartAssist, followed by Impella-supported OPCABG using a sternotomy approach with shunting of the coronary arteries to achieve myocardial protection.

Sponsors & Collaborators

  • Abiomed Inc.

    collaborator INDUSTRY
  • Lucian Archambault Durham III

    lead OTHER

Principal Investigators

  • Lucian A Durham, MD, PhD · Medical College of Wisconsin

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-11
Primary Completion
2025-12-31
Completion
2026-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT04339452 on ClinicalTrials.gov