Epicardial Device Implant for Mitral Regurgitation

(ENRAPTUS Trial)

Overseen By Laura A Minarsch

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mitre Medical Corp.

Must be taking: Heart failure therapy

Must not be taking: Intravenous inotropes

Disqualifiers: Mitral valve disease, Cardiogenic shock, Renal insufficiency, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a device called the Mitral Touch System, designed to assist individuals with mitral regurgitation, a condition where the heart's mitral valve fails to close properly, causing blood to flow backward. Researchers aim to determine if this device can safely enhance heart function during planned heart surgeries. Individuals with moderate to severe mitral regurgitation who are already scheduled for heart surgery may qualify for this trial. As an unphased trial, it offers patients the chance to contribute to innovative research that could improve future heart surgery outcomes.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that within 90 days, patients should be on stable, optimally adjusted medical therapy for heart failure as recommended by current guidelines.

What prior data suggests that the Mitral Touch System is safe for treating mitral regurgitation?

Research shows that the Mitral Touch System, which reshapes the heart's valve without open-heart surgery, appears safe. Although specific data on this system is limited, similar treatments for mitral valve issues have been very successful. For instance, one study found that a different system had a 96% success rate, with a 6% mortality rate within 30 days. These findings suggest that procedures like the Mitral Touch System are generally well-tolerated.

The trial is in a "Not Applicable" phase, indicating limited safety data may be available. However, researchers usually design these trials with great care to ensure participant safety. Consulting a medical professional about any concerns is advisable to understand what these results mean. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Mitral Touch System because it offers a unique approach to treating mitral regurgitation without the need for open-heart surgery. Unlike traditional treatments, which often require cardiopulmonary bypass and open-heart access, this device is implanted epicardially, meaning it reshapes the mitral valve and left ventricle from the outside of the heart. This less invasive method could potentially reduce recovery times and complications associated with more invasive surgeries, providing a safer and more efficient option for patients.

What evidence suggests that the Mitral Touch System is effective for mitral regurgitation?

Research has shown that the Mitral Touch System, which participants in this trial will receive, could help treat mitral regurgitation, a condition where blood leaks backward through the mitral valve. In early studies, patients experienced a reduction in leaking blood by about 44% to 46% over a year, which proved beneficial. Although heart function showed a slight change, with ejection fraction moving from 34.6% to between 32% and 39.5%, the procedure remained generally safe. The Mitral Touch System reshapes the area around the mitral valve without needing to stop or open the heart. This method may assist patients with moderate to severe mitral regurgitation, especially those undergoing heart surgery. ^{2 6 7 8 9}

Who Is on the Research Team?

Robert L Smith II, MD

Principal Investigator

Baylor Scott and White Medical Center

Are You a Good Fit for This Trial?

This trial is for adults over 22 with moderate to severe ischemic or functional mitral regurgitation who are stable on heart failure therapy and scheduled for cardiac surgery. Exclusions include very weak heart function, advanced heart failure symptoms, large mitral valves, pregnancy, certain kidney issues, abnormal cardiac anatomy, prior valve interventions, and more.

Inclusion Criteria

I have been on a stable heart failure treatment for the last 90 days.

Patient is willing and able to sign Informed Consent Form

I am 22 years old or older.

Exclusion Criteria

My heart condition severely limits my physical activity.

The investigator believes you have serious, permanent high blood pressure in your lungs.

I cannot undergo procedures that require stopping my heart and lungs.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Device Implantation

Epicardially reshape the mitral valve annulus and left ventricle using the Mitral Touch System without cardiopulmonary bypass

Procedure

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Mitral Touch System

Trial Overview The trial tests the Mitral Touch System's safety and performance in reshaping the mitral valve annulus during cardiac surgery. It aims to treat patients with significant mitral insufficiency through either a sternotomy or thoracotomy approach.

How Is the Trial Designed?

Group I: Device Implantation Experimental Treatment 1 Intervention

To epicardially reshape the mitral valve annulus and left ventricle without the need for cardiopulmonary bypass (CPB) and open-heart access (atriotomy) using an epicardial implant.

Who Is Running the Clinical Trial?

Mitre Medical Corp.

Lead Sponsor

Trials

3

Recruited

80+

BSWRI Cardiac Imaging Core Lab (CICL)

Collaborator

Trials

1

Recruited

10+

Published Research Related to This Trial

The CHAGALL trial demonstrated that a novel automated chordal system for implanting artificial mitral chords was technically successful in all 5 patients with severe mitral regurgitation, showing no or trace residual MR after 12 months.

There were no device-related complications, and all patients survived the initial 30 days, indicating the safety and efficacy of this new approach for mitral valve repair.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automated Implantation of Artificial Mitral Chords: Preliminary Results From the Feasibility Trial. Weber, A., Rucinskas, K., Janusauskas, V., et al.[2020]

The PASCAL system effectively treated severe mitral regurgitation (MR) in 92 patients, achieving a high overall success rate of 97.8%, with significant improvements in MR severity and patient quality of life at follow-up.

Patients experienced notable reductions in proBNP levels and pulmonary capillary wedge pressure, indicating improved heart function, with a low major adverse event rate of only 1.2% cardiovascular death at 30 days.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional and hemodynamic results after transcatheter mitral valve leaflet repair with the PASCAL device depending on etiology in a real-world cohort. Barth, S., Shalla, A., Kikec, J., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11855948/

Outcome Improvement with Last-Generation Devices in Mitral ... Our data showed that the use of the fourth-generation MitraClip device in the real world for the treatment of severe MR is safe and effective, ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0022522320333626

Mitral Valve First in human experience with an epicardial ... Regurgitant volume by transthoracic echocardiography decreased by 46% and 44% and the ejection fraction from 34.6% to 32.1% and 39.5%, at 1 and 12 months, ...

3. jtcvs.org jtcvs.org/article/S0022-5223(20)33362-6/fulltext

First in human experience with an epicardial beating heart ... Regurgitant volume by transthoracic echocardiography decreased by 46% and 44% and the ejection fraction from 34.6% to 32.1% and 39.5%, at 1 and ...

4. scai.org scai.org/clinical-trial-evaluate-safety-and-effectiveness-using-tendyne-mitral-valve-system-treatment

Clinical Trial to Evaluate the Safety and Effectiveness ... In the early experience of 100 patients at high or prohibitive surgical risk, technical success rate was 96% and, 30-day mortality was 6%. The Tendyne system ...

5. citoday.com citoday.com/news/coapt-5-year-data-demonstrate-benefits-of-mitral-teer-reveal-need-to-address-underlying-lv-dysfunction

COAPT 5-Year Data Demonstrate Benefits of Mitral TEER ... It was concluded that TEER of the mitral valve was safe, improved outcomes, and was associated with reductions in risks of death or HF ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11765563/

Safety and Efficacy in Mitral Regurgitation Management ... Results: A total of 83 patients [71% FMR, 66% male, median (IQR) age 70 (11) years] underwent TEER, with 100% procedural success. MR ≤ 2+ was achieved in 100% ...

7. drstewart.com drstewart.com/mitraclip-data-fact-sheet/

MitraClip Data Fact Sheet The findings demonstrated that MitraClip is the first therapy shown to improve prognosis by reducing secondary MR due to left ventricular dysfunction. Data from ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04396379?tab=history&a=3

Record History | ver. 3: 2021-02-22 | NCT04396379 To evaluate the safety and performance of the Mitral Touch System to treat mitral insufficiency in patients who are to undergo cardiac surgery with either a ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12138949/

A nationwide analysis of resource utilization and safety in ... Mitral TEER has become a safer and more efficient procedure with decreasing hospitalization length, adverse discharge rate, hospital costs and ...