Back to search results

The MITRAL II Pivotal Trial for Mitral Valve Disease

This study is for people aged 18 or older with severe mitral annular calcification (calcium buildup in the heart valve) and symptomatic mitral valve dysfunction, meaning your mitral valve isn't working well. This includes severe mitral stenosis (narrowing of the valve) or moderate to severe mitral regurgitation (leaky valve). The study is testing the safety and effectiveness of the Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA valves, delivered using a transseptal (through the wall between heart chambers) approach, for patients who cannot have standard surgery. Success will be measured by looking at all-cause mortality (death from any cause) and hospitalization for heart failure at one year. The current recruitment status is unclear, with a planned enrollment of 210 participants.

Study design
This is a prospective multicenter study with two groups: one receiving the transseptal ViMAC procedure (110 patients) and another receiving medical treatment only (up to 100 patients).
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least one year to assess all-cause mortality and hospitalization for heart failure.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04408430

The MITRAL II Pivotal Trial (Mitral Implantation of TRAnscatheter vaLves).

Recruiting
NAAges 18+InterventionalTreatment
Mayra Guerrero
~210 participants
Updated 2026-01-13 on ClinicalTrials.gov
What's tested:Transseptal ViMAC

At a glance

Recruiting sites
14 of 17 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary Safety Endpoint: All Cause Morality and Hospitalization for Heart Failure
Measured over 1 year.

Conditions

Mitral Annular Calcification
Mitral Stenosis
Mitral Regurgitation
Mitral Valve Disease

Explore related trials

Mitral Valve DisorderMitral Valve InsufficiencyMitral Valve StenosisPremature calcification of mitral annulus

Where it's being run

17 sites across 13 states
Arizona3
California2
Massachusetts2
Colorado1
District of Columbia1
Minnesota1
New York1
Oklahoma1

Study leadership

  • Mayra Guerrero, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Tatiana Kaptzan, Ph. D.
[email protected]
507-284-1610
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Exclusion

Native neo mitral annulus size \< 275 mm2 or \> 810 mm2 as measured by CT scan.
Significant risk of LVOT obstruction or valve embolization as assessed by CT core lab 17. Clinically (by neurologist) or neuroimaging confirmed stroke or transient ischemic attack (TIA) within 90 days of the procedure. 18. Estimated life expectancy \<12 months due to non-cardiac conditions. 19. Expectation that patient will not improve despite treatment of mitral valve dysfunction. 20. Active bacterial endocarditis within 180 days of procedure. 21. \- Severe right ventricular dysfunction as assessed by Echo core lab 22. \- Active infection requiring antibiotic therapy (subject may be a candidate after 2 weeks of antibiotic discontinuation. 23. \- Female who is pregnant or lactating. 24. \- Participating in another investigational device study. 25. \- Aortic valve disease requiring intervention. If aortic valve intervention is required, the AVR procedure should be performed first and if the patient remains symptomatic after AVR, may be presented for consideration for inclusion in this trial. 26. \- Severe fixed pulmonary hypertension (PASP ≥70 mmHg and more than 2/3 of the systemic systolic blood pressure). 27. \- Severe chronic obstructive pulmonary disease requiring continuous home oxygen. 28. \- The patient refuses mitral valve intervention 29. \- Recent symptomatic COVID-19 infection with residual symptoms that may affect the outcomes of this trial.

What this trial measures

  • Primary Safety Endpoint: All Cause Morality and Hospitalization for Heart Failure1 year.

    A non-hierarchical composite of all-cause mortality and hospitalization for heart failure.