Transseptal ViMAC for Mitral Valve Stenosis

Phase-Based Progress Estimates
Beth Israel Deaconess Medical Center, Boston, MAMitral Valve Stenosis+3 MoreTransseptal ViMAC - Device
All Sexes
What conditions do you have?

Study 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.

Eligible Conditions
  • Mitral Valve Stenosis
  • Mitral Annular Calcification
  • Mitral Valve Regurgitation
  • Mitral Valve Disease

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: 1 year.

1 year.
Additional Efficacy Endpoint - Days Alive Out of the Hospital
Additional Safety Endpoint - Hospitalizations at 1 year
Primary Safety Endpoint: All Cause Morality and Hospitalization for Heart Failure
Secondary Effectiveness Endpoint
30 days
Additional Efficacy Endpoint - MR severity at 30 days
Additional Endpoint: Procedural Success
Year 1
Additional Efficacy Endpoint - Mitral Valve Reintervention
Additional Safety Endpoint - Acute Kidney Injury
Additional Safety Endpoint - Blood Transfusion
Additional Safety Endpoint - Endocarditis
Additional Safety Endpoint - Hemolysis
Additional Safety Endpoint - New Aortic Valve Insufficiency
Additional Safety Endpoint - New LVOT Gradient
Additional Safety Endpoint - New Pacemaker Requirement
Additional Safety Endpoint - Stroke at 30 days and 1 year.
30 days.
Additional Efficacy Endpoint - Distance walked in 6 MWT at 30 days
Additional Efficacy Endpoint - KCCQ at 30 days
Additional Efficacy Endpoint - NYHA Class at 30 days.
Additional Endpoint: Device Success
Additional Safety Endpoint - Need for ASD Closure
Immediately after the intervention procedure.
Additional Endpoint: Technical Success

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Registry of untreated patients
1 of 2
Transseptal ViMAC
1 of 2

Active Control

Experimental Treatment

210 Total Participants · 2 Treatment Groups

Primary Treatment: Transseptal ViMAC · No Placebo Group · Phase 2 & 3

Transseptal ViMAC
Experimental Group · 1 Intervention: Transseptal ViMAC · Intervention Types: Device
Registry of untreated patientsNoIntervention Group · 1 Intervention: Registry of untreated patients · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year.

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
690 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The medical team agrees that the patient will likely benefit from valve implantation.

Frequently Asked Questions

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

"The listing on 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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.