Assessing the Microtech System for Heart Failure Patients Needing LVAD Implantation
An Early Feasibility Trial to Assess the Safety and Accuracy of the Microtech System in Heart Failure Patients Undergoing Left Ventricular Assist Device Implantation
This study is testing a new pressure sensor system during heart surgery to see if it can help patients who need a heart pump called an LVAD.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Sex | All |
| Sponsor | Microtech Medical Technologies, Ltd Industry-sponsored |
| Locations | 2 sites (New York, New York and 1 other locations) |
| Trial ID | NCT06682910 on ClinicalTrials.gov |
What this trial studies
The Microtech-LVAD study is a prospective, single-arm, multi-center feasibility assessment involving approximately 15 patients who require a left ventricular assist device (LVAD) implantation via midline sternotomy. Initially, the device will be implanted in the right atrium for the first five patients, after which it will be placed in the left atrium unless the patient is at high risk for post-LVAD right heart failure. Clinical data will be collected at various stages, including pre-operative, intra-operative, and multiple post-operative follow-ups up to 12 months. This study aims to evaluate the safety and accuracy of the Microtech sensor pressure system during the implantation process.
Who should consider this trial
Good fit: Ideal candidates are patients scheduled for elective LVAD implantation via midline sternotomy with an INTERMACS profile of 2 or greater.
Not a fit: Patients with pre-operative coagulopathy, certain existing cardiac devices, or recent thromboembolic events may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the safety and effectiveness of LVAD implantation for heart failure patients.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving LVAD implantation techniques.
Eligibility criteria
Show full inclusion / exclusion criteria
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: 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 access or closure of the atrium in which the device is intended to be implanted
Where this trial is running
New York, New York and 1 other locations
- Columbia University Medical Center/ NewYork Presbyterian Hospital or CUMC/NYPH — New York, New York, United States (Recruiting)
- Rabin Medical Center — Petach Tikvah, Israel (Recruiting)
Study contacts
- Study coordinator: Brenda Koltun Reuven
- Email: brendak@medinol.com
- Phone: +972542666688
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.