Mitral Valve Regurgitation: Transseptal Mitral Valve Replacement System - Early Feasibility Study

What is the Purpose of this Study?

The purpose of this study is to determine the safety and effectiveness of an investigational device called the Innovalve TMVR system for the treatment of a leaking mitral valve (mitral valve regurgitation). Mitral valve regurgitation happens when the heart’s mitral valve does not close tightly, allowing blood to flow backward in the heart. Stopping or decreasing mitral regurgitation helps blood flow more efficiently through the heart and the rest of the body. Researchers want to test this device because it is a less invasive procedure than open heart surgical replacement of the mitral valve. Innovalve’s Transseptal Mitral Valve Replacement System is an implantable bioprosthetic (artificial) mitral valve replacement device, meaning that once implanted, it will be in the same location as the patient’s native mitral valve and will function in its place.


Eligibility

  • Clinically significant, symptomatic mitral regurgitation
  • High risk for open-heart surgery
  • Meets anatomical criteria
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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

Prospective, single-arm, early feasibility study for the treatment of subjects with moderate-severe or severe symptomatic mitral valve regurgitation using the Innovalve Transseptal Mitral Valve Replacement System

Study Details
Disease Type/Condition

Mitral Valve Regurgitation

Principal Investigator

Makkar, Rajendra

Age Group

Adult

Phase

I

IRB Number

STUDY00002654

ClinicalTrials.gov ID

NCT04919980

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Email
clinicaltrials@cshs.org
Study Detail
Disease Type/Condition

Mitral Valve Regurgitation

Principal Investigator

Makkar, Rajendra

Age Group

Adult

Phase

I

IRB Number

TWIST-EFS

ClinicalTrials.gov ID

NCT04919980

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org