NCT06682910 · Microtech Medical Technologies, Ltd
Assessment of Safety and Accuracy of the Microtech System in Patients Undergoing Left Ventricular Assist Device Implantation
(Microtech-LVAD)
What this study is about
The Microtech-LVAD study is designed as a forward-looking, single treatment group$1, multi-center early feasibility study. Approximately 15 patients will be enrolled in the study. The study will be limited to patients in whom it is decided, based on routine clinical practice, that the LVAD will be implanted via a midline sternotomy.
View original scientific description
The Microtech-LVAD study is designed as a prospective, single arm, multi-center early feasibility study. Approximately 15 patients will be enrolled in the study. The study will be limited to patients in whom it is decided, based on routine clinical practice, that the LVAD will be implanted via a midline sternotomy.
Interventions
DEVICE
Microtech sensor pressure
Microtech sensor implantation
Primary outcome measures
Co-Primary Efficacy Endpoint
Time frame: 6 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 Endpoint
Time frame: 1 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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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:
- 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
Where
- New York, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 25, 2025 · Source of record for eligibility and locations