Assessment of Safety and Accuracy of the Microtech System in Patients Undergoing Left Ventricular Assist Device Implantation

Prior treatment

• For an intended LA implant, patient has a device implanted in the left atrial appendage (e.g., WATCHMAN or similar device) or a mechanical mitral valve
• Patient has a history of stroke or transient ischemic attack within 6 months prior to the index procedure
• Patient has severe mitral regurgitation (for an LA implant) or severe tricuspid regurgitation (for an RA implant) that is not intended to be corrected during the LVAD implantation
• Patient is pregnant or intends to become pregnant prior to completion of all protocol follow-up requirements
• Intraoperative identification of any anatomical finding that would preclude safe access to, or closure of, the intended atrial chamber, or fixation of the device within the chamber including, but not limited to:
  • Identification of thrombus in the atrium in which the device will be implanted
  • Atrial anatomy deemed to be too thin or fragile to accept the implant
  • Epicardial adhesions or any intraoperative finding that would complicate access or closure of the atrium in which the device is intended to be implanted

Other illness

• History of systemic or pulmonary thromboembolism or deep vein thrombosis (DVT) within the last 6 months
• Patient has a history of congenital heart disease, including known atrial septal defect that is not corrected (including during the LVAD implantation procedure)
• Patient has known allergy to stainless steel or titanium

Other

• Pre-operative coagulopathy or thrombocytopenia
• Patient has an atrial myxoma
• Patient has pre-operative evidence of thrombus in the chamber in which the device is intended to be implanted
• Patient has noncardiac comorbidity that, in the opinion of the Principal Investigator, may limit life expectancy to less than 1 year
• Patient is participating in another investigational study that has not reached its primary endpoint

• Patient is scheduled to undergo an elective LVAD implantation via midline sternotomy based on routine practice at the participating center.
• Patient is characterized as INTERMACS profile 2 or greater.
• Patient is able and willing to provide written informed consent.
• Patient is willing and able to comply with all required post-procedure follow-up visits.