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

10 Participants Needed

Trial Summary

What is the purpose of this trial?

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 sternotomy or thoracotomy who present with moderate to severe ischemic or functional mitral regurgitation.

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 data supports the effectiveness of the Mitral Touch System treatment for mitral regurgitation?

Research shows that the Mitral Touch System, an epicardial device, can effectively reduce mitral regurgitation (a condition where the heart's mitral valve doesn't close tightly) in animal models by reshaping the heart's structures. This suggests it may help improve heart function in similar human conditions. ^{1 2 3 4 5}

Is the epicardial device for mitral regurgitation safe for humans?

The first human experience with an epicardial device for mitral regurgitation suggests it can be used safely without needing to stop the heart during the procedure. ^{2 3 4 6 7}

How is the Mitral Touch System treatment for mitral regurgitation different from other treatments?

The Mitral Touch System is unique because it involves an epicardial device implant, which means it is placed on the outer surface of the heart, potentially offering a less invasive alternative to traditional surgical methods that require opening the heart or using a catheter through blood vessels. This approach may be beneficial for patients with limited vascular access or other complications that make standard procedures challenging. ^{8 9 10 11 12}

Research Team

Robert L Smith II, MD

Principal Investigator

Baylor Scott and White Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Novel epicardial off-pump device for mitral regurgitation: acute evaluation. [2019]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Acute reduction of functional mitral regurgitation in canine model using an epicardial device. [2008]

3. Germany pubmed.ncbi.nlm.nih.gov

PASCAL mitral valve repair system versus MitraClip: comparison of transcatheter edge-to-edge strategies in complex primary mitral regurgitation. [2022]

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

First in human experience with an epicardial beating heart device for secondary mitral regurgitation. [2023]

5. Netherlands 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. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Automated Implantation of Artificial Mitral Chords: Preliminary Results From the Feasibility Trial. [2020]

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

Risk and outcomes of complications during and after MitraClip implantation: Experience in 828 patients from the German TRAnscatheter mitral valve interventions (TRAMI) registry. [2016]

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

Subxiphoid approach to epicardial implantation of implantable cardioverter defibrillators in children. [2014]

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

Treatment of refractory ventricular fibrillation by combined internal (epicardial) and external (transthoracic) defibrillation. [2019]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Facilitated minimally invasive left ventricular epicardial lead placement. [2014]

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

Physiological optimization of robotic endoscopic epicardial CRT-D implantation using multielectrode electroanatomic mapping. [2020]

12. Portugal pubmed.ncbi.nlm.nih.gov

[Ventricular cardiac resynchronization--initial surgical experience]. [2007]