Ischemic Cardiomyopathy
Conditions
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
Interventions
DEVICEImpella 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
Abiomed Inc.
Lucian Archambault Durham III
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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) or Left main disease * Adequate Distal target caliber (as determined by the PI or operating surgeon)
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed