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

ClinicalTrials.gov ID: NCT04408430

Public ClinicalTrials.gov record NCT04408430. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced May 18, 2026, 6:14 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

The Safety and Effectiveness of the Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA (SAPIEN 3/Ultra/RESILIA) Valve in Patients With Symptomatic Severe Calcific Mitral Valve Disease With Severe Mitral Annular Calcification Who Are Not Candidates for Standard Mitral Valve Surgery.

Study identification

NCT ID: NCT04408430
Recruitment status: Recruiting
Study type: Interventional
Phase: Not applicable
Lead sponsor: Mayra Guerrero; Other
Enrollment: 210 participants

Conditions and interventions

Conditions

Interventions

Transseptal ViMAC Device

Device

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Mar 7, 2021
Primary completion: Nov 30, 2026
Completion: Nov 30, 2030
Last update posted: Jan 12, 2026

2021 – 2030

United States locations

U.S. sites: 16
U.S. states: 12
U.S. cities: 15

Facility	City	State	ZIP	Site status
Dignity Health Chandler Regional Medical Center	Gilbert	Arizona	85297	Recruiting
Banner - University Medicine Cardiology Clinic	Phoenix	Arizona	85006	Recruiting
Pima Heart & Vascular	Tucson	Arizona	85712	Recruiting
Cedars-Sinai Medical Center	Los Angeles	California	90048	Recruiting
Sutter Health	San Francisco	California	94109	Recruiting
Uchealth Heart & Vascular Clinic Harmony Campus	Fort Collins	Colorado	80528	Active, not recruiting
Medstar Washington Hospital Center	Washington D.C.	District of Columbia	200100	Recruiting
Massachusetts General Hospital	Boston	Massachusetts	02114	Recruiting
Brigham and Women's Hospital	Boston	Massachusetts	02115	Recruiting
Mayo Clinic	Rochester	Minnesota	55905	Active, not recruiting
Columbia University Medical Center/NYPH	New York	New York	10032	Recruiting
Oklahoma Heart Institute Utica Office	Tulsa	Oklahoma	74104	Recruiting
Oregon Health & Science University	Portland	Oregon	97239	Recruiting
University Health	San Antonio	Texas	78229	Recruiting
Intermountain Medical Center	Murray	Utah	84107	Recruiting
The Sentara Heart Valve and Structural Disease Center	Norfolk	Virginia	23507	Active, not recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT04408430, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jan 12, 2026 · Synced May 18, 2026

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The complete protocol, eligibility criteria, and contact information for NCT04408430 live on ClinicalTrials.gov.

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