Recruiting

Innovalve SystemTVMR With the INNOVALVE System Trial - Early Feasibility Study

Sponsor:

Edwards Lifesciences

Code:

NCT04919980

Conditions

Mitral Valve Regurgitation (Degenerative or Functional)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

INNOVALVE system

Study Details

Brief summary:

Study to evaluate the safety and performance of the INNOVALVE system

Conditions

Mitral Valve Regurgitation (Degenerative or Functional)

Study ID

NCT04919980

Start date

Sep 1, 2022

Status verified date

Apr, 2026

Completion date

Jul 1, 2031

Anticipated

Primary completion date

Jul 1, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

65 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment

MV replacement with INNOVALVE system

Interventions

INNOVALVE system

Primary outcome measure

Absence of implant or delivery related serious adverse events at 30 Days [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

TMTT Clinical

(949) 250-2500 TMTT_Clinical@edwards.com

Locations

Cedars-Sinai

Recruiting

Los Angeles, California, United States, 90048

Contacts

Mitch Gheorghiu

310-407-9553 Mitch.Gheorghiu@cshs.org

Principal Investigator:

Rajendra Makkar, MD

Stanford University

Recruiting

Palo Alto, California, United States, 94305

Contacts

Anushka Marathe

650-497-0903 amarathe@stanford.edu

Principal Investigator:

Alan Yeung, MD

Naples Comprehensive Health

Recruiting

Naples, Florida, United States, 34102

Contacts

Kathy Byrd

239-624-8113 kathy.byrd@nchmd.org

Principal Investigator:

Robert Cubeddu, MD

Emory University

Recruiting

Atlanta, Georgia, United States, 30308

Contacts

Elizabeth Charles

404-686-1249 echarl2@emory.edu

Principal Investigator:

Adam Greenbaum, MD

Piedmont Heart Institute

Recruiting

Atlanta, Georgia, United States, 30309

Contacts

Jennifer Bolivar Aldana

770-846-0344 jennifer.bolivaraldana@piedmont.org

Principal Investigator:

Vinod Thourani, MD

Northwestern

Recruiting

Chicago, Illinois, United States, 60611

Contacts

BCVI Clinical Trials Unit

312-926-4000 heartresearch@northwestern.edu

Principal Investigator:

Charles Davidson, MD

University of Michigan Hospital and Health Systems

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Keoni Fordham

734-763-6551 fordham@med.umich.edu

Principal Investigator:

Stanley Chetcuti, MD

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 555905

Contacts

Carl Griffin

griffinii.carl@mayo.edu

Principal Investigator:

Mackram Eleid, MD

Saint Luke's Hospital

Recruiting

Kansas City, Missouri, United States, 64111

Contacts

Brianna Vann

816-932-9614 bvann@saint-lukes.org

Principal Investigator:

Adnan Chhatriwalla, MD

Morristown Medical Center

Recruiting

Morristown, New Jersey, United States, 07960

Contacts

Catherine Van Zile

973-971-5951 catherine.vanzile@atlantichealth.org

Principal Investigator:

Gennaro Giustino, MD

Northwell Health

Recruiting

Manhasset, New York, United States, 11030

Contacts

Samantha Annunziato

516-600-1475 sannunziato@northwell.edu

Principal Investigator:

Bruce Rutkin, MD

NewYork-Presbyterian / Columbia University

Recruiting

New York, New York, United States, 10032

Contacts

Treena Williams

taw2112@cumc.columbia.edu

Principal Investigator:

Susheel Kodali, MD

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Emily Tylicki

216-444-6950 tylicke@ccf.org

Principal Investigator:

Samir Kapadia, MD

OhioHealth Research Institute

Recruiting

Columbus, Ohio, United States, 43214

Contacts

Katy Monnin

614-566-5768 katy.monnin@ohiohealth.com

Principal Investigator:

Carlos Sanchez, MD

Oregon Health & Science Universtiy

Recruiting

Portland, Oregon, United States, 97239

Contacts

Emmanuel Mills, MD

503-494-3925 millsem@ohsu.edu

Principal Investigator:

Firas Zahr, MD

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Kelli Cook

215-459-4478 kelli.cook@pennmedicine.upenn.edu

Principal Investigator:

Paul Fiorilli, MD

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Kathy Adams

615-322-9845 kathy.adams@vumc.org

Natalie Jackson

615-343-1782 natalie.jackson@vumc.org

Principal Investigator:

Colin M Barker, MD

Ascension Saint Thomas

Recruiting

Nashville, Tennessee, United States, 37205

Contacts

Emily Normandin

615-222-3852 emily.normandin@ascension.org

Principal Investigator:

Andrew Morse, MD

Swedish Medical Center

Recruiting

Seattle, Washington, United States, 98122

Contacts

Zaw Nu Dan

206-215-2431 zawnu.dan@swedish.org

Principal Investigator:

Sidakpal Panaich, MD

More Information

Sponsor

Edwards Lifesciences

Last update posted

May 28, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Edwards Lifesciences on 2026-05-28.