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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new device called the Microtech System for individuals with heart failure scheduled to receive an LVAD (a heart pump). Researchers seek to evaluate the device's performance when placed in various parts of the heart during surgery. The trial is recruiting individuals with severe heart failure who are set to receive an LVAD through chest surgery. Participants should not have certain heart conditions or recent blood clot issues. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance surgical outcomes for future patients.

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 prior data suggests that the Microtech System is safe for heart failure patients?

Research has shown that the Microtech System is promising in terms of safety. An earlier study reported the first human use of this tiny implantable sensor, and it appeared safe. Patients using the device did not experience major problems, and it accurately measured heart pressures over time.

The treatment remains in the early stages, with researchers primarily assessing its safety in people. So far, the Microtech System has been used successfully, with no major issues in obtaining accurate heart data from patients.

While more research is needed to confirm these findings, early results suggest that the Microtech System could be a safe option for people with heart failure. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Microtech System is unique because it offers a novel approach to managing heart failure, potentially setting it apart from standard treatments like ACE inhibitors, beta-blockers, and diuretics. Unlike these traditional medications, which primarily focus on symptom management and slowing disease progression, the Microtech System is designed to directly optimize heart function through advanced technology. Researchers are particularly excited about its potential to improve cardiac efficiency and patient quality of life without relying on drugs. This system could represent a significant leap forward in heart failure treatment by providing a more targeted and less invasive solution.

What evidence suggests that the Microtech System is effective for heart failure?

Research has shown that the Microtech System, which includes a tiny sensor implanted in the body, holds promise for treating heart failure. Early human trials demonstrated its ability to measure pressures in the heart, a crucial factor in managing heart failure. Previous studies have indicated that the device is safe, an essential consideration for patients receiving this treatment. While more data is needed, these early results suggest that the Microtech System could aid patients with heart failure by monitoring and managing their condition. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. mpo-mag.com mpo-mag.com/breaking-news/medinols-microtech-has-1st-human-case-of-implantable-microsensor-for-heart-failure/

Microtech Has 1st Human Case of Implantable Microsensor DISRUPT BTK II one-year outcomes data demonstrate strong safety profile and consistent effectiveness of the Shockwave Peripheral IVL system.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06334822

Study Details | NCT06334822 | Randomised Controlled ... This study aims to ascertain the device's practical effectiveness in real-world scenarios, aiming to collect precise data to confirm its potential benefits for ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06682910/assessment-of-safety-and-accuracy-of-the-microtech-system-in-patients-undergoing-left-ventricular-assist-device-implantation?mp=em&page=6&state=NY&city=Bronx

Assessment of Safety and Accuracy of the Microtech ... The Microtech-LVAD study is designed as a prospective, single arm, multi-center early feasibility study. Approximately 15 patients will be ...

4. clinicaltrial.be clinicaltrial.be/en/details/458463?per_page=20&only_recruiting=0&only_eligible=0&only_active=0

Assessment of Safety and Accuracy of the Microtech ... The Microtech-LVAD study is designed as a prospective, single arm, multi-center early feasibility study. Approximately 15 patients will be ...

5. medinol.com medinol.com/news/microtech-announces-first-human-case-of-implantable-microsensor-for-heart-failure-2/

Microtech Announces First Human Case of Implantable ... It has initiated human clinical trials of their microsensor platform, in a trial to measure atrial pressures important for the treatment of heart failure.

6. medtechspectrum.com medtechspectrum.com/news/42/24388/microtech-marks-milestone-with-first-u-s-atrial-microsensor-implantations.html

Microtech Marks Milestone with First U.S. Atrial ... The device's ability to non-invasively and accurately measure left and right atrial pressures over time offers clinicians valuable hemodynamic data, helping ...

7. finance.yahoo.com finance.yahoo.com/news/microtech-announces-first-human-case-110000249.html

Microtech Announces First Human Case of Implantable ... The data generated by the implanted sensors will be aggregated and used by Heart Failure specialists to inform clinical decision making for ...