Impella Supported OPCABG

N/AActive Not RecruitingNCT04339452

Lucian Archambault Durham III30 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Ischemic Cardiomyopathy

Interventions

Impella 5.5 with SmartAssist Supported OPCABGDEVICE

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

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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: * 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 * Suspected or known pregnancy

Locations (1)

The Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Outcomes

Primary Outcomes

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.

Time frame: Intraoperative

Data from ClinicalTrials.gov

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