Vanderbilt Clinical Trials

TVMR With the Innovalve System Trial - Early Feasibility Study

Purpose

Study to evaluate the safety and performance of the Innovalve mitral valve replacement system

Condition

Mitral Valve Regurgitation (Degenerative or Functional)

Eligibility

Eligible Ages: Over 18 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

Inclusion Criteria

Clinically significant, symptomatic mitral regurgitation - High risk for open-heart surgery - Meets anatomical criteria

Exclusion Criteria

Unsuitable anatomy - Patient is inoperable - EF<25%

Study Design

Phase: N/A
Study Type: Interventional
Allocation: N/A
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Treatment	MV replacement with Innovalve MR system	Device: Innovalve MR system Innovalve MR system

Recruiting Locations

Vanderbilt University Medical Center
Nashville, Tennessee 37203

Contact:
Kathy Adams
615-322-9845
kathy.adams@vumc.org

More Details

Status: Recruiting
Sponsor: Edwards Lifesciences

Study Contact

TMTT Clinical
(949) 250-2500
TMTT_Clinical@edwards.com

Detailed Description

The study is a multi-center, First-In-Human, prospective, single arm early feasibility study to evaluate the safety and performance of the Innovalve mitral valve replacement system

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.