An Early Feasibility Trial to Assess the Safety and Accuracy of the Microtech System in Heart Failure Patients Undergoing Left Ventricular Assist Device Implantation
Microtech Medical Technologies, Ltd
Summary
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. In the first 5 study patients, the device will be implanted in the RA; subsequently, the device will be implanted in the LA unless the patient is deemed at high risk of post-LVAD right heart failure, in which case the device will be placed in the RA
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. In the first 5 study patients, the device will be implanted in the RA; subsequently, the device will be implanted in the LA unless the patient is deemed at high risk of post-LVAD right heart failure, in which case the device will be placed in the RA. Clinical data will be collected…
Eligibility
- Age range
- Not specified
- Sex
- All
- Healthy volunteers
- No
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 mitra…
Interventions
- DeviceMicrotech sensor pressure
Microtech sensor implantation
Locations (2)
- Columbia University Medical Center/ NewYork Presbyterian Hospital or CUMC/NYPHNew York, New York
- Rabin Medical CenterPetach Tikvah