RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

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

Quick Facts

Study Start:2024-12-15

Study Completion:2026-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06682910

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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

Inclusion Criteria

Exclusion 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.

* 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

Contacts and Locations

Study Contact

Brenda Koltun Reuven

CONTACT

+972542666688

brendak@medinol.com

Study Locations (Sites)

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

New York, New York, 10032

United States

Collaborators and Investigators

Sponsor: Microtech Medical Technologies, Ltd

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-15

Study Completion Date2026-11

Study Record Updates

Study Start Date2024-12-15

Study Completion Date2026-11

Terms related to this study

Additional Relevant MeSH Terms

Heart Failure