TVMR With the INNOVALVE System Trial - Early Feasibility Study
Edwards Lifesciences · NCT04919980
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Not applicable
- Target enrollment
- 85
- US sites recruiting
- 19
- Study start
- September 1, 2022
- Record last updated
- September 21, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
Study to evaluate the safety and performance of the INNOVALVE system
Being studied: INNOVALVE system
Conditions: Mitral Valve Regurgitation (Degenerative or Functional)
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
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%
Recruiting US locations
Cedars-Sinai
Los Angeles, CA 90048
Site contact: Mitch Gheorghiu · 310-407-9553 · Mitch.Gheorghiu@cshs.org
Stanford University
Palo Alto, CA 94305
Site contact: Anushka Marathe · 650-497-0903 · amarathe@stanford.edu
Naples Comprehensive Health
Naples, FL 34102
Site contact: Kathy Byrd · 239-624-8113 · kathy.byrd@nchmd.org
Emory University
Atlanta, GA 30308
Site contact: Elizabeth Charles · 404-686-1249 · echarl2@emory.edu
Piedmont Heart Institute
Atlanta, GA 30309
Site contact: Jennifer Bolivar Aldana · 770-846-0344 · jennifer.bolivaraldana@piedmont.org
Northwestern
Chicago, IL 60611
Site contact: BCVI Clinical Trials Unit · 312-926-4000 · heartresearch@northwestern.edu
University of Michigan Hospital and Health Systems
Ann Arbor, MI 48109
Site contact: Keoni Fordham · 734-763-6551 · fordham@med.umich.edu
Henry Ford Health
Detroit, MI 48202
Site contact: Sahar Razmjou · 313-916-4475 · srazmjo1@hfhs.org
Mayo Clinic
Rochester, MN 555905
Site contact: Carl Griffin · griffinii.carl@mayo.edu
Saint Luke's Hospital
Kansas City, MO 64111
Site contact: Brianna Vann · 816-932-9614 · bvann@saint-lukes.org
Morristown Medical Center
Morristown, NJ 07960
Site contact: Catherine Van Zile · 973-971-5951 · catherine.vanzile@atlantichealth.org
Northwell Health
Manhasset, NY 11030
Site contact: Samantha Annunziato · 516-600-1475 · sannunziato@northwell.edu
Cleveland Clinic
Cleveland, OH 44195
Site contact: Emily Tylicki · 216-444-6950 · tylicke@ccf.org
OhioHealth Research Institute
Columbus, OH 43214
Site contact: Katy Monnin · 614-566-5768 · katy.monnin@ohiohealth.com
Oregon Health & Science Universtiy
Portland, OR 97239
Site contact: Emmanuel Mills, MD · 503-494-3925 · millsem@ohsu.edu
University of Pennsylvania
Philadelphia, PA 19104
Site contact: Kelli Cook · 215-459-4478 · kelli.cook@pennmedicine.upenn.edu
Vanderbilt University Medical Center
Nashville, TN 37203
Site contact: Kathy Adams · 615-322-9845 · kathy.adams@vumc.org
Ascension Saint Thomas
Nashville, TN 37205
Site contact: Emily Normandin · 615-222-3852 · emily.normandin@ascension.org
Swedish Medical Center
Seattle, WA 98122
Site contact: Zaw Nu Dan · 206-215-2431 · zawnu.dan@swedish.org
Study contacts (from the official record)
- TMTT Clinical · (949) 250-2500 · TMTT_Clinical@edwards.com