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Microtech System for Heart Failure Patients Undergoing LVAD Implantation

This study is testing the Microtech sensor pressure system in about 15 patients who are already scheduled to receive a Left Ventricular Assist Device (LVAD) for heart failure. The Microtech sensor will be implanted during your LVAD surgery. Researchers want to see how safe the Microtech system is one month after surgery, and how well it works after six months. To join, you must be scheduled for an elective LVAD implantation through a midline sternotomy (a cut down the middle of your chest) and have INTERMACS profile 2 or greater (a measure of your heart failure severity). This study is currently enrolling patients.

Study design
This is an early-stage study (feasibility study) that will include about 15 patients. All participants will receive the Microtech sensor, so there is no comparison group.
What's involved
You will have the Microtech sensor implanted during your LVAD surgery. Researchers will collect clinical data before, during, and after your surgery, at discharge, and at 1, 3-6, 9, and 12 months after your procedure.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for safety for one month and for how well the device works for six months. Data will also be collected at 1, 3-6, 9, and 12 months after your procedure.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06682910

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

Active, Not Recruiting
NAAll AgesInterventional
Microtech Medical Technologies, Ltd
~15 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:Microtech sensor pressure

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Co-Primary Efficacy Endpoint
Measured over 6 months
+1 more outcome measured

Conditions

Heart Failure

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Heart Failure

NCT06682910

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Columbia University Medical Center/ NewYork Presbyterian Hospital or CUMC/NYPH

    New York, New Yorkno site contact published

  • Rabin Medical Center

    Petach Tikvah, Israelno site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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.

Exclusion

Pre-operative coagulopathy or thrombocytopenia
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 an atrial myxoma
Patient has pre-operative evidence of thrombus in the chamber in which the device is intended to be implanted
Patient has a history of stroke or transient ischemic attack within 6 months prior to 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 septal defect that is not corrected (including during the LVAD implantation 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 has known allergy to stainless steel or titanium
Patient has noncardiac comorbidity that, in the opinion of the Principal Investigator, may limit life expectancy to less than 1 year
Patient is pregnant or intends to become pregnant prior to completion of all protocol follow-up requirements
Patient is participating in another investigational study that has not reached its primary endpoint
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:

What this trial measures

  • Co-Primary Efficacy Endpoint6 months

    1. Successful deployment of the intracardiac sensor. 2. Freedom from failure of the Microtech System to obtain valid intracardiac pressures by at least one method (CW/DB), in at least one timepoint up to 6 months.

  • Co-Primary Safety Endpoint1 month

    1. Anatomic stability of the implant assessed by echocardiographic imaging through 1 month. 2. The incidence of device- or implant procedure-related adverse events through 1 month