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Transcatheter Valve

Transseptal ViMAC for Mitral Valve Disease (MITRAL-II Trial)

N/A
Recruiting
Led By Mayra Guerrero, MD
Research Sponsored by Mayra Guerrero
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Severe mitral annular calcification with symptomatic mitral valve dysfunction including severe mitral stenosis defined as mitral valve area (MVA) of ≤1.5 cm2, or ≥ moderate to severe mitral regurgitation, or mixed ≥ moderated stenosis and ≥ moderate regurgitation graded according to the 2017 American Society of Echocardiography Guidelines
Candidates must be 18 years of age or older
Must not have
Active infection requiring antibiotic therapy
Severe left ventricular dysfunction with LVEF < 20%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year.
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new surgical technique, Transseptal Valve-in-MAC, for patients with severe mitral annular calcification and symptomatic mitral valve disease who are at high surgical risk. The control arm will receive medical treatment only.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects aren't listed here, similar procedures may cause bleeding, infection risks at the catheter entry site, irregular heartbeats or potential damage to nearby structures like other valves or vessels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have severe heart valve issues with symptoms according to specific measurements.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently on antibiotics for an infection.
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My heart's left ventricle is severely weakened.
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I need emergency surgery.
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I haven't needed heart or lung support machines in the last 30 days.
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I have chosen not to undergo mitral valve surgery.
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I have a heart condition that blocks blood flow and my heart's measurements meet specific criteria.
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My heart's mitral valve ring does not have severe calcium buildup.
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My heart's shape or size doesn't allow for certain valve replacement procedures.
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I need treatment for my aortic valve disease.
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I have severe, unchangeable high blood pressure in my lungs.
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I need constant oxygen at home for my severe lung condition.
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I have serious heart artery problems that haven't been treated with surgery.
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My heart's right side is not pumping well.
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I recently had COVID-19 with ongoing symptoms.
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I am currently pregnant or breastfeeding.
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I have a history of blood disorders or clotting problems.
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I need surgery for severe heart valve leakage.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Primary Safety Endpoint: All Cause Morality and Hospitalization for Heart Failure
Secondary study objectives
Secondary Effectiveness Endpoint
Other study objectives
Additional Efficacy Endpoint - Days Alive Out of the Hospital
Additional Efficacy Endpoint - Distance walked in 6 MWT at 30 days
Additional Efficacy Endpoint - KCCQ at 30 days
+16 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Transseptal ViMACExperimental Treatment1 Intervention
110 MAC patients treated with transseptal Valve-in-MAC.
Group II: Registry of untreated patientsActive Control1 Intervention
100 MAC patients not eligible for transseptal ViMAC, treated with conservative management including medications.

Find a Location

Who is running the clinical trial?

Mayra GuerreroLead Sponsor
1 Previous Clinical Trials
91 Total Patients Enrolled
Mayra Guerrero, MDPrincipal Investigator - Mayo Clinic
Mayo Clinic Hospital-Rochester Saint Marys Campus
University Auto De Baja California (Medical School)
Wm Beaumont Hospital (Residency)
4 Previous Clinical Trials
1,103 Total Patients Enrolled

Media Library

Transseptal ViMAC (Transcatheter Valve) Clinical Trial Eligibility Overview. Trial Name: NCT04408430 — N/A
~45 spots leftby Dec 2025
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