Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04408430 · ClinicalTrials.gov registry record · NA
The MITRAL II Pivotal Trial (Mitral Implantation of TRAnscatheter vaLves).
A NA study of Mitral Regurgitation and Mitral Valve Disease, sponsored by Mayra Guerrero.
- Recruiting
- Registry status
- NA
- Development phase
- 210
- Enrollment target
- 17
- Study locations
NCT04408430: Recruiting NA study of Mitral Regurgitation and Mitral Valve Disease, sponsored by Mayra Guerrero.
NCT04408430 is a NA study of Mitral Regurgitation and Mitral Valve Disease that is actively recruiting participants, run by Mayra Guerrero. The registered enrollment target is 210 participants, below the 1,016-participant average among 26 other Mitral Regurgitation trials with a reported enrollment target (79% lower). The trial reports 17 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04408430, a NA study of Mitral Regurgitation and Mitral Valve Disease, is actively recruiting participants, sponsored by Mayra Guerrero.
- RECRUITING
- Registry status
- NA
- Development phase
- 210 participants
- Enrollment target
- 17
- Study locations
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.
Primary Outcome
A non-hierarchical composite of all-cause mortality and hospitalization for heart failure.
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 |
What NCT04408430 shows while recruiting
NCT04408430 is an interventional study that assigns participants to a tested intervention. The registered 210 participants enrollment target is mid-sized for trials with a published cap, below the 1,016-participant average among 26 other Mitral Regurgitation trials with a reported enrollment target (79% lower).
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.
NCT04408430 lists 17 locations in 13 states (Arizona, California, Massachusetts).
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.
What interventions are being tested in trial NCT04408430?
The interventions under investigation include: Transseptal ViMAC (DEVICE).
Who is sponsoring clinical trial NCT04408430?
This trial is sponsored by Mayra Guerrero, which has 2 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Mitral Regurgitation
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04408430's enrollment target sits among peer trials
210 12th of 26 higher than 15 of 26 other Mitral Regurgitation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Mitral Regurgitation trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
An Early Feasibility Study of the HighLife 28mm Trans-Septal Transcatheter Mitral Valve Replacement System
RECRUITING · NA
-
EFS of the CardioMech MVRS
RECRUITING · NA
-
Transcatheter Mitral Valve Repair for Inotrope Dependent Cardiogenic Shock
RECRUITING · NA
-
Cephea Early Feasibility Study
RECRUITING · NA
-
Evaluating Infrasonic Hemodynography
RECRUITING · NA
-
The CardioClip Study
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02665923 · 210 participants
Gastric Emptying in Neonates and Infants After Formula Feeding
- NCT03322891 · 210 participants · NA
Improving Health Literacy in African-American Prostate Cancer Patients
- NCT03544489 · 210 participants · Phase 2
Effectiveness of Exercise After an ICD
- NCT04460573 · 210 participants · Phase 2
Smart Boot Use to Measure Offloading Adherence
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI