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Transcatheter Valve

Transseptal ViMAC for Mitral Valve Disease (MITRAL-II Trial)

N/A

Recruiting

Led By Mayra Guerrero, MD

Research Sponsored by Mayra Guerrero

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Severe mitral annular calcification with symptomatic mitral valve dysfunction including severe mitral stenosis defined as mitral valve area (MVA) of ≤1.5 cm2, or ≥ moderate to severe mitral regurgitation, or mixed ≥ moderated stenosis and ≥ moderate regurgitation graded according to the 2017 American Society of Echocardiography Guidelines

Candidates must be 18 years of age or older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year.

Awards & highlights

MITRAL-II Trial Summary

This trial is testing a new surgical technique, Transseptal Valve-in-MAC, for patients with severe mitral annular calcification and symptomatic mitral valve disease who are at high surgical risk. The control arm will receive medical treatment only.

Who is the study for?

This trial is for adults over 18 with severe heart valve calcification and symptoms of mitral valve disease who are at high risk for standard surgery. They must be able to follow up for five years post-procedure. Exclusions include certain heart conditions, active infections, recent strokes or heart attacks, severe lung or blood disorders, pregnancy, and participation in another device study.Check my eligibility

What is being tested?

The MITRAL II Trial tests a new procedure called Transseptal Valve-in-MAC (ViMAC) against medical treatment only in patients with severe mitral annular calcification. It's designed to see if ViMAC can help those who are too risky for traditional surgery.See study design

What are the potential side effects?

While specific side effects aren't listed here, similar procedures may cause bleeding, infection risks at the catheter entry site, irregular heartbeats or potential damage to nearby structures like other valves or vessels.

MITRAL-II Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have severe heart valve issues with symptoms according to specific measurements.

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I am 18 years old or older.

MITRAL-II Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Primary Safety Endpoint: All Cause Morality and Hospitalization for Heart Failure

Secondary outcome measures

Secondary Effectiveness Endpoint

Other outcome measures

Additional Efficacy Endpoint - Days Alive Out of the Hospital

Additional Efficacy Endpoint - Distance walked in 6 MWT at 30 days

Additional Efficacy Endpoint - KCCQ at 30 days

+16 more

MITRAL-II Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Transseptal ViMACExperimental Treatment1 Intervention

110 MAC patients treated with transseptal Valve-in-MAC.

Group II: Registry of untreated patientsActive Control1 Intervention

100 MAC patients not eligible for transseptal ViMAC, treated with conservative management including medications.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayra GuerreroLead Sponsor

1 Previous Clinical Trials

91 Total Patients Enrolled

Mayra Guerrero, MDPrincipal Investigator - Mayo Clinic

Mayo Clinic Hospital-Rochester Saint Marys Campus

University Auto De Baja California (Medical School)

Wm Beaumont Hospital (Residency)

4 Previous Clinical Trials

1,088 Total Patients Enrolled

Media Library

Transseptal ViMAC (Transcatheter Valve) Clinical Trial Eligibility Overview. Trial Name: NCT04408430 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any patients that fit the criteria for this research study currently being accepted?

"The listing on clinicaltrials.gov confirms that this research is actively recruiting patients. The 210 participants will be drawn from 22 different locations; the study was first posted on March 8th, 2021."

Answered by AI

Where can patients receive this type of treatment?

"Beth Israel Deaconess Medical Center in Boston, Columbia University Medical Center in Detroit, and Brigham and Women's Hospital in Tulsa are all running this clinical trial, among other hospitals in 22 additional locations."

Answered by AI

How many people are being asked to take part in this research project?

"In order to run this study as planned, the research team needs to enroll 210 individuals that fit the pre-specified inclusion criteria. Beth Israel Deaconess Medical Center in Boston, Massachusetts and Columbia University Medical Center in Detroit, Michigan are two of the many locations where potential participants can reside."

Answered by AI