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Tests treatment safety and results for Heart Failure
Official title Assessment of Safety and Accuracy of the Microtech System in Patients Undergoing Left Ventricular Assist Device Implantation
ClinicalTrials.gov ID: NCT06682910
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- 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.
You likely can't join if
- 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...
- 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
See the full eligibility 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
- Petach Tikvah, Israel
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States; Petach Tikvah, Israel. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.