Assessment of Safety and Accuracy of the Microtech System in Patients Undergoing Left Ventricular Assist Device Implantation

NCT06682910 | Recruiting DMC FDA Device

• 1 other identifier: Microtech-001
• Study Type: interventional
• Target: 15
• Locations: 2 countries
• Sites: 2

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

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (2)

• Co-Primary Efficacy Endpoint

  1. Successful deployment of the intracardiac sensor. 2. Freedom from failure of the Microtech System to obtain valid intracardiac pressures by at least one method (CW/DB), in at least one timepoint up to 6 months.

  6 months

• Co-Primary Safety Endpoint

  1. Anatomic stability of the implant assessed by echocardiographic imaging through 1 month. 2. The incidence of device- or implant procedure-related adverse events through 1 month

  1 month

Secondary Outcomes (7)

• The earliest post-operative day at which "valid" pressure measurements can be made from the Microtech implant

  1 month

• Accuracy of Microtech pressure measurements in comparison to those obtained simultaneously by pulmonary artery catheter

  pre procedure, 3-6 months

• Accuracy of Microtech pressure measurements in comparison to those obtained simultaneously by pulmonary artery catheter

  1 year

• Anatomic stability of the implant over the observation period

  post operation, 1 month, 3-6 months, 9 months, 12 months

• The incidence of device-related adverse events

  12 months

Study Arms (1)

Microtech System

EXPERIMENTAL

Microtech System

Device: Microtech sensor pressure

Interventions

Microtech sensor pressure DEVICE

Microtech sensor implantation

Microtech System

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify 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 may not qualify 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 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

Sponsors & Collaborators

• Microtech Medical Technologies, Ltd: lead

Study Sites (2)

Columbia University Medical Center/ NewYork Presbyterian Hospital or CUMC/NYPH

New York, New York, 10032, United States

RECRUITING

Rabin Medical Center

Petach Tikvah, Israel

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Brenda Koltun Reuven

CONTACT

+972542666688; brendak@medinol.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2024
• First Posted: November 12, 2024
• Study Start: December 15, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); IL (1)