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NCT Number: NCT04339452

Impella Supported OPCABG

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Ischemic Cardiomyopathy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Intraoperative hemodynamic stability

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Lucian Archambault Durham III

Other

Collaborators

  • Abiomed Inc.

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Apr 9, 2020
Registry last updated
Jan 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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