Actively Recruiting
The MITRAL II Pivotal Trial (Mitral Implantation of TRAnscatheter vaLves).
Led by Mayra Guerrero · Updated on 2026-01-13
210
Participants Needed
17
Research Sites
507 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The MITRAL II Pivotal Trial (Mitral Implantation of TRAnscatheter vaLves).
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Severe mitral annular calcification with symptomatic mitral valve dysfunction including severe mitral stenosis (mitral valve area 31 1.5 cm2), or 31 moderate to severe mitral regurgitation, or mixed 31 moderate stenosis and 31 moderate regurgitation
- New York Heart Association (NYHA) Functional Class II or higher
- Heart team agrees that valve implantation would likely benefit the patient
- High or prohibitive risk for standard mitral valve surgery as determined by heart team
- Patient has provided informed consent and agrees to comply with post-procedure follow-up visits including annual visits through 5 years
You will not qualify if you...
- Patient is considered a surgical candidate by heart team
- Mitral annulus is not severely calcified
- Myocardial infarction requiring revascularization within 30 days prior to procedure
- Untreated significant coronary artery disease requiring revascularization
- Any invasive cardiac procedure with permanent implant within 30 days prior to index procedure (except permanent pacemaker)
- Balloon mitral valvuloplasty within 30 days prior (unless bridge to ViMAC after qualifying Echo)
- Severe symptomatic tricuspid regurgitation requiring surgery
- Leukopenia (WBC < 3000 cells/mL), acute anemia (Hgb < 9 g/dL), thrombocytopenia (platelets < 50,000 cells/mL), history of coagulopathy or hypercoagulable state
- Hypertrophic obstructive cardiomyopathy with specified LVOT gradients
- Hemodynamic or respiratory instability requiring support within 30 days prior
- Need for emergency surgery
- Severe left ventricular dysfunction (LVEF < 20%)
- Intracardiac mass, thrombus, or vegetation by echocardiography
- Active upper gastrointestinal bleeding within 90 days prior
- Contraindication or hypersensitivity to anticoagulation or inability to anticoagulate
- Cardiac anatomy unsuitable for valve delivery via transseptal access
- Stroke or transient ischemic attack within 90 days
- Life expectancy less than 12 months due to non-cardiac conditions
- Expectation of no improvement despite treatment
- Active bacterial endocarditis within 180 days
- Severe right ventricular dysfunction
- Active infection requiring antibiotics (may be candidate after 2 weeks off antibiotics)
- Pregnant or lactating female
- Participation in another investigational device study
- Aortic valve disease requiring intervention without prior AVR
- Severe fixed pulmonary hypertension
- Severe chronic obstructive pulmonary disease requiring continuous oxygen
- Patient refuses mitral valve intervention
- Recent symptomatic COVID-19 infection with residual symptoms affecting outcomes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 17 locations
1
Dignity Health Chandler Regional Medical Center
Gilbert, Arizona, United States, 85297
Actively Recruiting
2
Banner - University Medicine Cardiology Clinic
Phoenix, Arizona, United States, 85006
Actively Recruiting
3
Pima Heart & Vascular
Tucson, Arizona, United States, 85712
Actively Recruiting
4
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
5
Sutter Health
San Francisco, California, United States, 94109
Actively Recruiting
6
Uchealth Heart & Vascular Clinic Harmony Campus
Fort Collins, Colorado, United States, 80528
Active, Not Recruiting
7
Medstar Washington Hospital Center
Washington D.C., District of Columbia, United States, 200100
Actively Recruiting
8
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
9
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
10
Mayo Clinic
Rochester, Minnesota, United States, 55905
Active, Not Recruiting
11
Columbia University Medical Center/NYPH
New York, New York, United States, 10032
Actively Recruiting
12
Oklahoma Heart Institute Utica Office
Tulsa, Oklahoma, United States, 74104
Actively Recruiting
13
Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
14
University Health
San Antonio, Texas, United States, 78229
Actively Recruiting
15
Intermountain Medical Center
Murray, Utah, United States, 84107
Actively Recruiting
16
The Sentara Heart Valve and Structural Disease Center
Norfolk, Virginia, United States, 23507
Active, Not Recruiting
17
Ignacio Chávez National Institute of Cardiology
Mexico City, Mexico, 14080
Actively Recruiting
Research Team
T
Tatiana Kaptzan, Ph. D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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