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

Inclusion Criteria:

• Patient is scheduled to undergo an elective LVAD implantation via midline sternotomybased 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-upvisits.

Exclusion Criteria:

• Pre-operative coagulopathy or thrombocytopenia

• For an intended LA implant, patient has a device implanted in the left atrialappendage (e.g., WATCHMAN or similar device) or a mechanical mitral valve

• Patient has an atrial myxoma

• Patient has pre-operative evidence of thrombus in the chamber in which the device isintended to be implanted

• Patient has a history of stroke or transient ischemic attack within 6 months priorto the index procedure

• 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 septaldefect that is not corrected (including during the LVAD implantation procedure)

• Patient has severe mitral regurgitation (for an LA implant) or severe tricuspidregurgitation (for an RA implant) that is not intended to be corrected during theLVAD implantation

• Patient has known allergy to stainless steel or titanium

• Patient has noncardiac comorbidity that, in the opinion of the PrincipalInvestigator, may limit life expectancy to less than 1 year

• Patient is pregnant or intends to become pregnant prior to completion of allprotocol follow-up requirements

• Patient is participating in another investigational study that has not reached itsprimary endpoint

• Intraoperative identification of any anatomical finding that would preclude safeaccess to, or closure of, the intended atrial chamber, or fixation of the devicewithin the chamber including, but not limited to:

1. Identification of thrombus in the atrium in which the device will be implanted

2. Atrial anatomy deemed to be too thin or fragile to accept the implant

3. Epicardial adhesions or any intraoperative finding that would complicate accessor closure of the atrium in which the device is intended to be implanted