Microtech System for Heart Failure
(Microtech-LVAD Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Microtech Medical Technologies, Ltd

No Placebo Group

Trial Summary

What is the purpose of this trial?

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

Research Team

Eligibility Criteria

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.

Inclusion Criteria

I can attend all follow-up visits after my procedure.

Patient is characterized as INTERMACS profile 2 or greater

Patient is able and willing to provide written informed consent

See 1 more

Exclusion Criteria

Patient is participating in another investigational study that has not reached its primary endpoint

Pre-operative coagulopathy or thrombocytopenia

Patient has known allergy to stainless steel or titanium

See 10 more

Treatment Details

Interventions

Microtech System (Device)

Trial OverviewThe 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.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Microtech SystemExperimental Treatment1 Intervention

Microtech System