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Device

Microtech System for Heart Failure (Microtech-LVAD Trial)

N/A
Waitlist Available
Research Sponsored by Microtech Medical Technologies, Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient is scheduled to undergo an elective LVAD implantation via midline sternotomy based on routine practice at the participating center
Must not have
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 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month, 3-6 months , 9months and 12 month
Awards & highlights
No Placebo-Only Group

Summary

This trial will involve 15 patients who will receive a heart pump device called LVAD via surgery. The first few patients will have the device placed in the right side of the heart, and then in

Who is the study for?
This trial is for patients who are scheduled to receive a Left Ventricular Assist Device (LVAD) through midline sternotomy, based on routine clinical decisions. It's not clear what specific conditions exclude someone from participating.
What is being tested?
The study tests the safety and accuracy of the Microtech sensor pressure system in patients getting an LVAD implant. Initially, 5 patients will have it placed in the right atrium (RA), with subsequent placements in the left atrium (LA) unless there's a high risk of right heart failure post-LVAD.
What are the potential side effects?
Since this trial focuses on device implementation rather than medication, side effects may include typical surgical risks such as infection or complications related to device placement like bleeding or improper sensor readings.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am scheduled for a heart pump implant surgery through the chest.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a device like WATCHMAN implanted in my heart's left atrial appendage or a mechanical mitral valve.
Select...
I have severe heart valve issues not being fixed during my heart pump implant.
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I have been diagnosed with a heart tumor known as atrial myxoma.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month, 3-6 months , 9months and 12 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month, 3-6 months , 9months and 12 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Co-Primary Efficacy Endpoint
Co-Primary Safety Endpoint
Secondary study objectives
Accuracy of Microtech pressure measurements in comparison to those obtained simultaneously by pulmonary artery catheter
Anatomic stability of the implant over the observation period
Correlation of changes of sensor-measured atrial pressure
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Microtech SystemExperimental Treatment1 Intervention
Microtech System

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Who is running the clinical trial?

Microtech Medical Technologies, LtdLead Sponsor
~10 spots leftby May 2026
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