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

Overview

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

Interventions

• Device Microtech sensor pressure
  Microtech sensor implantation

Primary outcome measures

• Co-Primary Efficacy Endpoint [Time frame: 6 months]
• Co-Primary Safety Endpoint [Time frame: 1 month]

Secondary outcome measures (7)

• The earliest post-operative day at which "valid" pressure measurements can be made from the Microtech implant [Time frame: 1 month]
• Accuracy of Microtech pressure measurements in comparison to those obtained simultaneously by pulmonary artery catheter [Time frame: pre procedure, 3-6 months]
• Accuracy of Microtech pressure measurements in comparison to those obtained simultaneously by pulmonary artery catheter [Time frame: 1 year]
• Anatomic stability of the implant over the observation period [Time frame: post operation, 1 month, 3-6 months, 9 months, 12 months]
• The incidence of device-related adverse events [Time frame: 12 months]
• Correlation of changes of sensor-measured atrial pressure [Time frame: 1 month, 3-6 months , 9months and 12 month]
• Usability of the system [Time frame: baseline, 30-6 months, 12 months]

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:

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Other

Study locations

United States · 1 center

• Columbia University Medical Center/ NewYork Presbyterian Hospital or CUMC/NYPH — New York

Israel · 1 center

• Rabin Medical Center — Petach Tikvah

Identifiers

NCT: NCT06682910 · Microtech-001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗