Impella Supported OPCABG

Ischemic Cardiomyopathy Clinical Trial

Official title:

Impella-supported Off-pump Coronary Artery Bypass Grafting in High Risk Revascularizations: A Single Center Prospective Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04339452
• Other study ID #: 37481
• Status: Recruiting
• Start date: May 11, 2022
• Est. completion date: March 2025

Study information

• Verified date: February 2023
• Source: Medical College of Wisconsin
• Contact: Krissa Packard, MS
• Phone: 4149551861
• Email: kpackard[@]mcw.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 2025
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Ischemic Cardiomyopathy

Intervention

Device:
• Impella 5.0 and Impella 5.5 with SmartAssist Supported OPCABG
Subjects will undergo insertion of an axillary or ascending aortic Impella 5.0 Device or Impella 5.5 with SmartAssist, followed by Impella supported OPCABG using a sternotomy approach with shunting of the coronary arteries to achieve myocardial protection.

Locations

Country	Name	City	State
United States	The Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Lyle Joyce	Abiomed Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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