Impella Supported OPCABG

NCT04339452 | Active Not Recruiting DMC FDA Device

• 1 other identifier: 37481
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Ischemic Cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• Intraoperative hemodynamic stability

  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.

  Intraoperative

Interventions

Impella 5.5 with SmartAssist Supported OPCABG DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients fitting inclusion criteria will undergo Impella supported OPCABG using coronary shunts. Inclusion criteria will target patients with ischemic cardiomyopathy, similarly defined to the STICH trial which evaluated coronary revascularization in the setting of heart failure (defined by an EF≤35%). Patients would be considered for enrollment in the setting of symptomatic severe multi-vessel coronary artery disease with target vessels that are amenable to bypass (as determined by the operating surgeon).

You may qualify if:

• 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) or Left main disease
• Adequate Distal target caliber (as determined by the PI or operating surgeon)

You may not qualify if:

• 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
• Suspected or known pregnancy

Sponsors & Collaborators

• Lucian Archambault Durham III: lead
• Abiomed Inc.: collaborator

Study Sites (1)

The Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Study Officials

• Lucian A Durham, MD, PhD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lucian Durham, MD, PhD

Study Record Dates

• First Submitted: March 10, 2020
• First Posted: April 9, 2020
• Study Start: May 11, 2022
• Primary Completion: December 1, 2025
• Study Completion: March 1, 2026
• Last Updated: January 27, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)