Transseptal ViMAC for Mitral Valve Disease

(MITRAL-II Trial)

Recruiting at 26 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

185 Participants Needed

Trial Summary

What is the purpose of this trial?

A prospective multicenter study enrolling high surgical risk patients with severe mitral annular calcification (MAC) and symptomatic mitral valve dysfunction (severe stenosis, ≥ moderate to severe regurgitation, or mixed ≥ moderate stenosis and ≥ regurgitation). There are 2 Arms in this study: 1) "Transseptal (TS) Valve-in-MAC" (ViMAC) Arm, and 2) Natural History of Disease Registry (NHDR) for patients treated with medical treatment only (which includes patients who meet inclusion criteria but can't be treated with transeptal ViMAC due to the presence of anatomical exclusion criteria or other exclusion criteria) and have not had other procedures that may impact outcomes (i.e., alcohol septal ablation or radiofrequency ablation). The study also includes a Registry of Permanently Unassigned" for subjects who undergo preemptive septal ablation procedures (alcohol or radiofrequency) in anticipation of continuing onto ViMAC arm, but are not accepted in the ViMAC Study arm or the patient chooses not to undergo ViMAC procedure.

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.

What data supports the effectiveness of the treatment Transseptal ViMAC for Mitral Valve Disease?

Research suggests that the transseptal approach for mitral valve-in-valve procedures, which is similar to Transseptal ViMAC, may lead to faster recovery, better heart function, and possibly lower mortality compared to the transapical approach. This is based on data from case series and a large international registry. ^{1 2 3 4 5}

Is Transseptal ViMAC generally safe for humans?

A study on transseptal transcatheter mitral valve replacement for severe mitral regurgitation showed it is feasible and relatively safe, with some patients experiencing major cardiovascular events like heart rhythm issues and heart failure readmission within 30 days. ^{1 6 7 8 9}

How is the Transseptal ViMAC treatment different from other treatments for mitral valve disease?

Transseptal ViMAC is unique because it uses a less invasive approach through the femoral vein, avoiding the need to open the chest, which can lead to faster recovery and potentially lower mortality compared to traditional surgical methods or other transcatheter approaches like transapical access. ^{1 2 4 6 10}

Research Team

Mayra Guerrero, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

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

Early outcomes following transatrial transcatheter mitral valve replacement in patients with severe mitral annular calcification. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Transcatheter mitral valve replacement for degenerated mitral valve bioprostheses, failure of mitral valvuloplasty and native valve with severe mitral annulus calcification: a systematic review and meta-analysis. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Transseptal vs Transapical Transcatheter Mitral Valve-in-Valve and Valve-in-Ring Implantation: A Systematic Review and Meta-Analysis. [2023]

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

Transseptal transcatheter mitral valve-in-valve: A step by step guide from preprocedural planning to postprocedural care. [2019]

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

Prospective Study of TMVR Using Balloon-Expandable Aortic Transcatheter Valves in MAC: MITRAL Trial 1-Year Outcomes. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Transseptal mitral valve-in-valve implantation in a degenerated mitral bioprosthesis: A case report and literature review. [2021]

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

Transcatheter Mitral Valve Replacement With the Transseptal EVOQUE System. [2021]

8. China pubmed.ncbi.nlm.nih.gov

[Feasibility and safety of transseptal transcatheter mitral valve replacement for severe mitral regurgitation]. [2023]

9. France pubmed.ncbi.nlm.nih.gov

Transcatheter valve-in-valve implantation versus redo surgical mitral valve replacement in patients with failed mitral bioprostheses. [2023]

10. China pubmed.ncbi.nlm.nih.gov

A step-by-step guide to transseptal valve-in-valve transcatheter mitral valve replacement. [2021]