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Impella Supported OPCABG

Sponsor
David Joyce, MD, MBA (Other)
Overall Status
Recruiting
CT.gov ID
NCT04339452
Collaborator
Abiomed Inc. (Industry)
30
Enrollment
1
Location
33.7
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
  • Device: Impella 5.0 and Impella 5.5 with SmartAssist Supported OPCABG

Study Design

Study Type:
Observational
Anticipated Enrollment :
30 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Impella-supported Off-pump Coronary Artery Bypass Grafting in High Risk Revascularizations: A Single Center Prospective Observational Study
Actual Study Start Date :
May 11, 2022
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
Mar 1, 2025

Outcome Measures

Primary Outcome Measures

  1. Intraoperative hemodynamic stability [Intraoperative]

    Intraoperative hemodynamic stability, defined as mean arterial pressure (MAP), cardiac index (CI), central venous pressure (CVP), and cerebral perfusion as measured by NIRS maintained within normal ranges for the entire operative time except potentially for short periods not exceeding 10 minutes in total time.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Age ≥ 18 years old

  • Ejection fraction ≤ 35%

  • Symptomatic three vessel Coronary Artery Disease with target vessels that are amenable to bypass (as determined by the operating surgeon)

  • Adequate Distal target caliber (as determined by the PI)

Exclusion Criteria:

  • Exclusion criteria will include the existing contraindications to either Impella therapy or OPCABG revascularization:

  • Patients with structural heart disease requiring cardiopulmonary bypass

  • Patients with cardiogenic shock who require a period of short-term mechanical circulatory support

  • Patients with mechanical aortic valve

  • Patients with previous median sternotomy

  • Patients with evidence of non-viability on preoperative cardiac MRI or CT scan

  • Insufficient conduit

  • BMI over 50

  • Patients who are COVID-19 positive at the time of screening

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Medical College of Wisconsin Milwaukee Wisconsin United States 53226

Sponsors and Collaborators

  • David Joyce, MD, MBA
  • Abiomed Inc.

Investigators

  • Principal Investigator: David L Joyce, MD, MBA, Medical College of Wisconsin

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
David Joyce, MD, MBA, David Joyce, MD, MBA, Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT04339452
Other Study ID Numbers:
  • 37481
First Posted:
Apr 9, 2020
Last Update Posted:
May 19, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:
Cardiomyopathies

Study Results

No Results Posted as of May 19, 2022