Microtech System for Heart Failure

(Microtech-LVAD Trial)

Recruiting at 1 trial location

Overseen By Brenda Koltun Reuven

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Microtech Medical Technologies, Ltd

Disqualifiers: Coagulopathy, Thrombocytopenia, Stroke, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

15 Participants Needed

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

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What data supports the effectiveness of the Microtech System treatment for heart failure?

The research highlights that similar treatments like cardiac resynchronization therapy (CRT) and mechanical circulatory support (MCS) devices have shown benefits in heart failure patients by improving survival and quality of life. These treatments help by synchronizing heartbeats or supporting heart function, suggesting that the Microtech System might offer similar advantages. ^{1 2 3 4 5}

How does the Microtech System treatment for heart failure differ from other treatments?

The Microtech System treatment for heart failure is unique because it utilizes advanced micro and nanotechnologies, which are being explored for cardiovascular applications to improve diagnosis, management, and therapy. This approach is different from traditional treatments that mainly focus on pharmacological regulation, as it aims to integrate micro- and nanoscale technologies to enhance the structural and functional repair of the heart. ^{6 7 8 9 10}

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

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative

Clinical data collection and preparation for LVAD implantation

1 week

1 visit (in-person)

Intra-operative

Implantation of the Microtech System during LVAD surgery

1 day

Surgical procedure

Post-operative Hospitalization

Monitoring and data collection during post-operative hospitalization

1 month

Daily monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Visits at 1, 3-6, 9, and 12 months

Treatment Details

Interventions

• Microtech System

Trial Overview 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.

Participant Groups

Group I: Microtech System Experimental Treatment 1 Intervention

Microtech System

Who Is Running the Clinical Trial?

Microtech Medical Technologies, Ltd

Lead Sponsor

Trials

1

Recruited

20+

References

1. Singapore pubmed.ncbi.nlm.nih.gov

Device trials in heart failure: a focused summary. [2007]

2. United States pubmed.ncbi.nlm.nih.gov

Rationale, design, and baseline characteristics of a Program to Assess and Review Trending INformation and Evaluate CorRelation to Symptoms in Patients with Heart Failure (PARTNERS HF). [2008]

3. United States pubmed.ncbi.nlm.nih.gov

Miniaturization of mechanical circulatory support systems. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Symptomatic relief: left ventricular assist devices versus resynchronization therapy. [2007]

5. Italy pubmed.ncbi.nlm.nih.gov

[Mechanical assist devices in advanced heart failure. Indications and perspectives]. [2007]

6. United States pubmed.ncbi.nlm.nih.gov

Management of cardiovascular diseases with micro systems and nanotechnology. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Microsystems: applications in implanted devices. [2016]

8. England pubmed.ncbi.nlm.nih.gov

Three-dimensional scaffold-free microtissues engineered for cardiac repair. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Portable bioreactor for perfusion and electrical stimulation of engineered cardiac tissue. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Establishment of a heart-on-a-chip microdevice based on human iPS cells for the evaluation of human heart tissue function. [2021]