Clinical trial NCT06682910: Assessment of Safety and Accuracy of the Microtech System in Patients Undergoing Left Ventricular Assist Device Implantation
Official title: An Early Feasibility Trial to Assess the Safety and Accuracy of the Microtech System in Heart Failure Patients Undergoing Left Ventricular Assist Device Implantation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Lead sponsor: Microtech Medical Technologies, Ltd
Sponsor class: INDUSTRY
First posted: 2024-11-12
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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

Detailed 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 pre-operatively, intra-operatively, throughout the post-operative hospitalization period, at discharge and at 1, 3-6, 9 and 12 months post-index procedure

Eligibility 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

Primary outcomes:
measure: Co-Primary Efficacy Endpoint
timeFrame: 6 months
measure: Co-Primary Safety Endpoint
timeFrame: 1 month
Secondary outcomes:
measure: The earliest post-operative day at which "valid" pressure measurements can be made from the Microtech implant
timeFrame: 1 month
measure: Accuracy of Microtech pressure measurements in comparison to those obtained simultaneously by pulmonary artery catheter
timeFrame: pre procedure, 3-6 months
measure: Accuracy of Microtech pressure measurements in comparison to those obtained simultaneously by pulmonary artery catheter
timeFrame: 1 year
measure: Anatomic stability of the implant over the observation period
timeFrame: post operation, 1 month, 3-6 months, 9 months, 12 months
measure: The incidence of device-related adverse events
timeFrame: 12 months
measure: Correlation of changes of sensor-measured atrial pressure
timeFrame: 1 month, 3-6 months , 9months and 12 month
measure: Usability of the system
timeFrame: baseline, 30-6 months, 12 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center/ NewYork Presbyterian Hospital or CUMC/NYPH
state: New York
city: Petach Tikvah
country: Israel
facility: Rabin Medical Center
Study officials:
References: