RecruitingNot ApplicableNCT06682910

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

An Early Feasibility Trial to Assess the Safety and Accuracy of the Microtech System in Heart Failure Patients Undergoing Left Ventricular Assist Device Implantation

Sponsor

Microtech Medical Technologies, Ltd

Enrollment

15 participants

Start Date

Dec 15, 2024

Study Type

INTERVENTIONAL

Conditions

Heart Failure

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

Eligibility

Plain Language Summary

Simplified for easier understanding

This study tests the safety and accuracy of the Microtech system — a small sensor device — that is implanted inside the heart during left ventricular assist device (LVAD) surgery to monitor heart pressures in patients with severe heart failure. **You may be eligible if...** - You are scheduled for a planned LVAD implant surgery (a mechanical pump to help the heart pump blood) - Your condition is classified as INTERMACS profile 2 or better (meaning you are seriously ill but not in immediate crisis) - You are able to provide consent and attend follow-up visits **You may NOT be eligible if...** - You have a blood clotting disorder or low platelets before surgery - You have a device already in your left atrial appendage (e.g., WATCHMAN device) or a mechanical mitral heart valve (for some implant locations) - You have a known blood clot in your heart or a history of stroke/TIA Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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