Transseptal ViMAC for Mitral Valve Disease

(MITRAL-II Trial)

Recruiting at 28 trial locations

Overseen By Tatiana Kaptzan, Ph. D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayra Guerrero

Disqualifiers: Coronary artery disease, Tricuspid regurgitation, Coagulopathy, Stroke, others

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

Compensation: Varies

Number of Visits: 30

Duration: 30 days

210 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new procedure for individuals with severe mitral valve problems, particularly when the valve is calcified and malfunctioning. One group will receive the new transseptal Valve-in-MAC (ViMAC) treatment, while the other group will continue with their usual medical care for observation. Individuals with serious mitral valve issues, who experience symptoms like shortness of breath or fatigue, and are considered high-risk for traditional surgery may be suitable candidates for this study. As an unphased trial, this study offers a unique opportunity to contribute to medical advancements and potentially benefit from innovative treatments.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that patients with a known contraindication or hypersensitivity to all anticoagulation regimens are excluded, which might imply some medication adjustments could be necessary. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the Transseptal ViMAC procedure yields mixed results. One study found similar procedures were technically successful approximately 77% of the time, but the death rate was about 54% within a year. Another study reported that around 10% of patients did not survive the first 30 days post-procedure. These findings indicate that while the procedure is feasible, significant risks exist, particularly for patients already at high surgical risk. Considering these risks is crucial when contemplating participation in a clinical trial for this treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Transseptal ViMAC is unique because it offers a novel approach to treating mitral valve disease by using a transseptal Valve-in-MAC (ViMAC) technique. Unlike traditional surgeries that require open-heart procedures, this method is minimally invasive, which might reduce recovery time and risks associated with more invasive surgeries. Researchers are excited about this treatment because it has the potential to provide a new option for patients who are not candidates for standard surgical interventions, offering them a safer and less invasive alternative.

What evidence suggests that this trial's treatments could be effective for mitral valve disease?

Research shows that the Transseptal ViMAC treatment, available to participants in this trial, could be promising for patients with severe mitral valve issues. Early results suggest it can significantly reduce mitral regurgitation—when blood leaks backward through the mitral valve—in over 94% of patients. Most treated patients experienced a substantial improvement in valve function. However, there is a significant risk of complications, such as blockage in the heart's blood flow, occurring in about 39.7% of cases. Despite these risks, the treatment has been technically successful for most patients, offering hope for those with limited options. ^{1 2 4 6 7}

Who Is on the Research Team?

Mayra Guerrero, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults over 18 with severe heart valve calcification and symptoms of mitral valve disease who are at high risk for standard surgery. They must be able to follow up for five years post-procedure. Exclusions include certain heart conditions, active infections, recent strokes or heart attacks, severe lung or blood disorders, pregnancy, and participation in another device study.

Inclusion Criteria

NYHA Functional Class ≥II

The heart team agrees that valve implantation will likely benefit the patient

I have severe heart valve issues with symptoms according to specific measurements.

Exclusion Criteria

I am currently on antibiotics for an infection.

My heart's left ventricle is severely weakened.

I had a heart attack and needed a procedure to improve blood flow within the last 30 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Edwards SAPIEN 3, SAPIEN 3 Ultra, or SAPIEN 3 Ultra RESILIA valve via the transseptal Valve-in-MAC procedure

30 days

Multiple visits for procedure and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of device success and procedural success

1 year

Regular follow-up visits at 30 days and 1 year

Registry Follow-up

Participants in the Natural History of Disease Registry are monitored for outcomes without intervention

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Transseptal ViMAC

Trial Overview

The MITRAL II Trial tests a new procedure called Transseptal Valve-in-MAC (ViMAC) against medical treatment only in patients with severe mitral annular calcification. It's designed to see if ViMAC can help those who are too risky for traditional surgery.

How Is the Trial Designed?

Group I: Transseptal ViMAC Experimental Treatment 1 Intervention

110 MAC patients treated with transseptal Valve-in-MAC.

Group II: Registry of untreated patients Active Control 1 Intervention

100 MAC patients not eligible for transseptal ViMAC, treated with conservative management including medications.

Who Is Running the Clinical Trial?

Mayra Guerrero

Lead Sponsor

Trials

2

Recruited

280+

Published Research Related to This Trial

The study evaluated the feasibility and safety of transseptal transcatheter mitral valve replacement (TSMVR) in four patients with severe mitral regurgitation, achieving technical success with no residual regurgitation or major complications immediately after the procedure.

While the procedure was deemed relatively safe, three major cardiovascular events occurred within 30 days, indicating the need for careful monitoring and further research on long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Feasibility and safety of transseptal transcatheter mitral valve replacement for severe mitral regurgitation]. Chen, F., Zhao, ZG., Yao, YJ., et al.[2023]

The EVOQUE transseptal transcatheter mitral valve replacement (TMVR) system was successfully used in 14 patients with moderate to severe mitral regurgitation, achieving a technical success rate of 92.9%.

At 30 days post-procedure, 83.3% of patients had no mitral regurgitation, and 81.8% showed improved functional status, indicating that this less invasive approach may be effective for high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter Mitral Valve Replacement With the Transseptal EVOQUE System. Webb, J., Hensey, M., Fam, N., et al.[2021]

Citations

1.

jacc.org

jacc.org/doi/10.1016/j.jacc.2022.09.037

2-Year Outcomes of Transcatheter Mitral Valve ...

In the 1-year outcomes of the MITRAL trial, excellent 1-year survival (97%) was demonstrated in mitral valve-in-valve (MViV), whereas ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10339466/

Transcatheter Mitral Valve Replacement in Patients with Mitral ...

For these patients, technical success rate was 62.1%. LVOT obstruction occurred most often with ViMAC TMVR cases (39.7%), while second valve implantation was ...

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S1936879824010355

Structural Outcomes Following Transcatheter Mitral Valve ...

MR ≤1+ was achieved in 94.3% and 95.1% of treated patients with MACmod/sev and MACnone/mild, respectively. The rates of MR elimination and ...

4.

ahajournals.org

ahajournals.org/doi/10.1161/CIRCINTERVENTIONS.119.008425

Thirty-Day Outcomes of Transcatheter Mitral Valve ...

Thirty-day clinical outcomes are shown in Table 4. All-cause mortality for the entire cohort was 10.1% and was higher in ViMAC patients (MViV= ...

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S247487062500260X

Mitral Annular Calcification: Understanding the Disease ...

Patients with MAC had lower survival particularly if mitral valve dysfunction was present (76% 1-year survival), compared with patients who had mitral valve ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8501192/

Early outcomes of transatrial mitral valve replacement in ...

Transatrial transcatheter mitral valve replacement can be performed safely with favorable short-term outcomes in high-surgical-risk patients with severe mitral ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12285396/

Mitral annular calcification in interventional cardiology

The MAC Global Registry found a technical success rate of 76.7% in TMVR procedures but noted a 1-year mortality rate of 53.7%, primarily due to ...