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Study identifier: NCT04408430 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Mitral Annular Calcification · Mitral Stenosis · Mitral Regurgitation  ·  Sponsor: Mayra Guerrero

PhaseNA
Planned participants210
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Tatiana Kaptzan, Ph. D.  ·  507-284-1610  ·  kaptzan.tatiana@mayo.edu

Always discuss trial participation with your own doctor first.

Locations (17)

Dignity Health Chandler Regional Medical CenterGilbert, Arizona, United StatesRecruiting
Banner - University Medicine Cardiology ClinicPhoenix, Arizona, United StatesRecruiting
Pima Heart & VascularTucson, Arizona, United StatesRecruiting
Cedars-Sinai Medical CenterLos Angeles, California, United StatesRecruiting
Sutter HealthSan Francisco, California, United StatesRecruiting
Uchealth Heart & Vascular Clinic Harmony CampusFort Collins, Colorado, United StatesActive Not Recruiting
Medstar Washington Hospital CenterWashington D.C., District of Columbia, United StatesRecruiting
Massachusetts General HospitalBoston, Massachusetts, United StatesRecruiting
Brigham and Women's HospitalBoston, Massachusetts, United StatesRecruiting
Mayo ClinicRochester, Minnesota, United StatesActive Not Recruiting
Columbia University Medical Center/NYPHNew York, New York, United StatesRecruiting
Oklahoma Heart Institute Utica OfficeTulsa, Oklahoma, United StatesRecruiting

+ 5 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT04408430