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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.
* Patient is characterized as INTERMACS profile 2 or greater.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group

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

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year 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

Find a Location

Who is running the clinical trial?

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