TVMR With the INNOVALVE System Trial - Early Feasibility Study

Purpose

Study to evaluate the safety and performance of the INNOVALVE system

Condition

  • Mitral Valve Regurgitation (Degenerative or Functional)

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
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

ArmDescriptionAssigned Intervention
Experimental
Treatment 		MV replacement with INNOVALVE system
  • Device: INNOVALVE system
    INNOVALVE system

Recruiting Locations

Cedars-Sinai
Los Angeles 5368361, California 5332921 90048
Contact:
Mitch Gheorghiu
310-407-9553
Mitch.Gheorghiu@cshs.org

Naples Comprehensive Health
Naples 4165565, Florida 4155751 34102
Contact:
Kathy Byrd
239-624-8113
kathy.byrd@nchmd.org

Piedmont Heart Institute
Atlanta 4180439, Georgia 4197000 30309
Contact:
Jennifer Bolivar Aldana
770-846-0344
jennifer.bolivaraldana@piedmont.org

Northwestern
Chicago 4887398, Illinois 4896861 60611
Contact:
BCVI Clinical Trials Unit
312-926-4000
heartresearch@northwestern.edu

University of Michigan Hospital and Health Systems
Ann Arbor 4984247, Michigan 5001836 48109
Contact:
Keoni Fordham
734-763-6551
fordham@med.umich.edu

Mayo Clinic
Rochester 5043473, Minnesota 5037779 555905
Contact:
Carl Griffin
griffinii.carl@mayo.edu

Morristown Medical Center
Morristown 5101427, New Jersey 5101760 07960
Contact:
Catherine Van Zile
973-971-5951
catherine.vanzile@atlantichealth.org

Northwell Health
Manhasset 5125766, New York 5128638 11030
Contact:
Samantha Annunziato
516-600-1475
sannunziato@northwell.edu

NewYork-Presbyterian / Columbia University
New York 5128581, New York 5128638 10032
Contact:
Treena Williams
taw2112@cumc.columbia.edu

Cleveland Clinic
Cleveland 5150529, Ohio 5165418 44195
Contact:
Emily Tylicki
216-444-6950
tylicke@ccf.org

OhioHealth Research Institute
Columbus 4509177, Ohio 5165418 43214
Contact:
Katy Monnin
614-566-5768
katy.monnin@ohiohealth.com

Oregon Health & Science Universtiy
Portland 5746545, Oregon 5744337 97239
Contact:
Emmanuel Mills, MD
503-494-3925
millsem@ohsu.edu

University of Pennsylvania
Philadelphia 4560349, Pennsylvania 6254927 19104
Contact:
Kelli Cook
215-459-4478
kelli.cook@pennmedicine.upenn.edu

Vanderbilt University Medical Center
Nashville 4644585, Tennessee 4662168 37203
Contact:
Kathy Adams
615-322-9845
kathy.adams@vumc.org

Ascension Saint Thomas
Nashville 4644585, Tennessee 4662168 37205
Contact:
Emily Normandin
615-222-3852
emily.normandin@ascension.org

Swedish Medical Center
Seattle 5809844, Washington 5815135 98122
Contact:
Zaw Nu Dan
206-215-2431
zawnu.dan@swedish.org

More Details

NCT ID
NCT04919980
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 system

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center