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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 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.

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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.

Conditions Studied

Mitral Regurgitation Mitral Valve Disease Mitral Stenosis Mitral Annular Calcification

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

FieldValue
Enrollment Target 210 participants
Start Date 2021-03-08
Est. Completion 2030-12
Phase NA

Sponsor

Mayra Guerrero

2 total trials

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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, categorized as NA. The registered enrollment target is 210 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,016-participant average among 26 other Mitral Regurgitation trials with a reported enrollment target (79% lower). The listed sponsor is Mayra Guerrero, which has 2 total studies on file at ClinicalTrials.gov.

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 reports 17 study locations spanning 13 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.