Actively Recruiting
TVMR With the INNOVALVE System Trial - Early Feasibility Study
Led by Edwards Lifesciences · Updated on 2026-01-30
65
Participants Needed
17
Research Sites
460 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Study to evaluate the safety and performance of the INNOVALVE system
CONDITIONS
Official Title
TVMR With the INNOVALVE System Trial - Early Feasibility Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinically significant, symptomatic mitral regurgitation
- High risk for open-heart surgery
- Meets anatomical criteria
You will not qualify if you...
- Unsuitable anatomy
- Patient is inoperable
- Ejection fraction less than 25%
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 17 locations
1
Cedars-Sinai
Los Angeles, California, United States, 90048
Actively Recruiting
2
Naples Comprehensive Health
Naples, Florida, United States, 34102
Actively Recruiting
3
Piedmont Heart Institute
Atlanta, Georgia, United States, 30309
Actively Recruiting
4
Northwestern
Chicago, Illinois, United States, 60611
Actively Recruiting
5
University of Michigan Hospital and Health Systems
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
6
Mayo Clinic
Rochester, Minnesota, United States, 555905
Actively Recruiting
7
Morristown Medical Center
Morristown, New Jersey, United States, 07960
Actively Recruiting
8
Northwell Health
Manhasset, New York, United States, 11030
Actively Recruiting
9
Cornell
New York, New York, United States, 10021
Withdrawn
10
NewYork-Presbyterian / Columbia University
New York, New York, United States, 10032
Actively Recruiting
11
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
12
OhioHealth Research Institute
Columbus, Ohio, United States, 43214
Actively Recruiting
13
Oregon Health & Science Universtiy
Portland, Oregon, United States, 97239
Actively Recruiting
14
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
15
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37203
Actively Recruiting
16
Ascension Saint Thomas
Nashville, Tennessee, United States, 37205
Actively Recruiting
17
Swedish Medical Center
Seattle, Washington, United States, 98122
Actively Recruiting
Research Team
T
TMTT Clinical
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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