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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04339452
Other study ID # 37481
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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