Open Atrial Transcatheter Mitral Valve Replacement in Patients With Mitral Annular Calcification.
Hyde M Russell, Mayra E Guerrero, Michael H Salinger...
https://pubmed.ncbi.nlm.nih.gov/30236304Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID04408430
The Safety and Effectiveness of the Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA Valve in Patients With Severe Calcific Mitral Valve Disease Who Are Not Candidates for Standard Surgery
Led by Mayra Guerrero · Updated on 2026-01-13
210
Participants Needed
17
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the safety and effectiveness of the Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA valves using the Commander delivery system in patients with severe mitral annular calcification (MAC) and symptomatic mitral valve dysfunction who are at high risk for standard mitral valve surgery. The study includes patients with severe mitral stenosis, moderate to severe mitral regurgitation, or a combination of both, focusing on those who are not candidates for traditional surgery due to their surgical risk. Participants are divided into two groups: one group receives the transseptal Valve-in-MAC (ViMAC) procedure using balloon-expandable aortic transcatheter valves, while the other group is a natural history registry of patients treated with medical management alone due to anatomical or other exclusion criteria. The study also includes a registry for patients who undergo preemptive septal ablation procedures but do not proceed with the ViMAC procedure. The treatment arm plans to enroll 110 patients, and the medically managed arm up to 100 patients. During the study, participants will be monitored through follow-up visits including annual visits for up to five years. Researchers will assess safety outcomes such as all-cause mortality and hospitalization for heart failure over one year. Effectiveness measures will also be evaluated at one year. Patients will undergo clinical evaluations and imaging to track valve function and overall heart health. The study spans from the screening and treatment phases through long-term follow-up to gather comprehensive data on patient outcomes.
CONDITIONS
Brief Title
The MITRAL II Pivotal Trial (Mitral Implantation of TRAnscatheter vaLves).
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Severe mitral annular calcification with symptomatic mitral valve dysfunction including severe mitral stenosis (mitral valve area ≤1.5 cm2), moderate to severe mitral regurgitation, or mixed moderate stenosis and moderate regurgitation
- NYHA Functional Class II or higher
- Heart team agrees valve implantation is likely beneficial
- High or prohibitive risk for standard mitral valve surgery as determined by a cardiac surgeon
- Informed consent provided and agreement to comply with post-procedure follow-up visits including annual visits up to 5 years
You will not qualify if you...
- Considered surgical candidate by heart team
- Mitral annulus not severely calcified
- Myocardial infarction requiring revascularization within 30 days before procedure
- Untreated significant coronary artery disease requiring revascularization
- Therapeutic invasive cardiac procedure with permanent implant within 30 days prior (except planned strategy)
- Balloon valvuloplasty within 30 days unless bridge to ViMAC after qualifying Echo
- Severe symptomatic tricuspid regurgitation requiring surgery
- Leukopenia, acute anemia, thrombocytopenia, coagulopathy, or hypercoagulable state
- Hypertrophic obstructive cardiomyopathy with specified LVOT gradients
- Hemodynamic or respiratory instability needing support within 30 days
- Emergency surgery needed
- Severe left ventricular dysfunction (LVEF <20%)
- Intracardiac mass, thrombus or vegetation
- Active upper GI bleeding within 90 days
- Contraindication or hypersensitivity to anticoagulation or inability to anticoagulate
- Cardiac anatomy unsuitable for transseptal valve delivery including specified annulus size and risk of obstruction or embolization
- Stroke or TIA within 90 days
- Life expectancy less than 12 months due to non-cardiac conditions
- Expected lack of improvement despite treatment
- Active bacterial endocarditis within 180 days
- Severe right ventricular dysfunction
- Active infection requiring antibiotics (candidate after 2 weeks off antibiotics)
- Pregnant or lactating female
- Participation in another investigational device study
- Aortic valve disease requiring intervention unless resolved first
- Severe fixed pulmonary hypertension
- Severe chronic obstructive pulmonary disease requiring continuous home oxygen
- Patient refuses mitral valve intervention
- Recent symptomatic COVID-19 infection with residual symptoms
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Procedure day
Participants receive transseptal transcatheter mitral valve replacement using balloon-expandable aortic transcatheter valves.
1 procedure visit (in-person)
Post-operative Follow-up
Duration - Up to 1 year
Participants are monitored after the valve implantation to assess safety and valve function.
Scheduled follow-up visits during the year
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
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Research Team
T
Tatiana Kaptzan, Ph. D.
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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https://pubmed.ncbi.nlm.nih.gov/29699609