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The MITRAL II Pivotal Trial (Mitral Implantation of TRAnscatheter vaLves).
NCT04408430 · View on ClinicalTrials.gov ↗
Study Summary
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 Studied
Interventions
- DEVICE Transseptal ViMAC
Study Locations (17)
Arizona
- Dignity Health Chandler Regional Medical Center — Gilbert
- Banner - University Medicine Cardiology Clinic — Phoenix
- Pima Heart & Vascular — Tucson
California
- Cedars-Sinai Medical Center — Los Angeles
- Sutter Health — San Francisco
Massachusetts
- Massachusetts General Hospital — Boston
- Brigham and Women's Hospital — Boston
Colorado
- Uchealth Heart & Vascular Clinic Harmony Campus — Fort Collins
District of Columbia
- Medstar Washington Hospital Center — Washington D.C.
Minnesota
- Mayo Clinic — Rochester
New York
- Columbia University Medical Center/NYPH — New York
Oklahoma
- Oklahoma Heart Institute Utica Office — Tulsa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 210 participants |
| Start Date | 2021-03-08 |
| Est. Completion | 2030-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04408430
The ClinicalTrials.gov registry entry for NCT04408430 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 210 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mayra Guerrero, which has 32 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Mitral Regurgitation appearing as the primary indexed condition, and to 1 intervention — of which Transseptal ViMAC is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04408430 reports 17 study locations spanning 13 distinct geographic areas — top geographies include Arizona, California, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04408430 about?
NCT04408430 is a clinical study titled "The MITRAL II Pivotal Trial (Mitral Implantation of TRAnscatheter vaLves).". 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) "T...
What is the current status of trial NCT04408430?
This trial is currently recruiting. It is a NA study. The enrollment target is 210 participants. The study started on 2021-03-08. Estimated completion is 2030-12.
What conditions does trial NCT04408430 study?
This clinical trial studies the following conditions: Mitral Regurgitation, Mitral Valve Disease, Mitral Stenosis, Mitral Annular Calcification. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04408430?
The interventions under investigation include: Transseptal ViMAC (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04408430?
This trial is sponsored by Mayra Guerrero, which has 32 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04408430 being conducted?
This trial has 17 study locations across Arizona, California, Colorado, District of Columbia, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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