Edwards Cardioband Tricuspid Valve Reconstruction System Early Feasibility Study



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 90
Updated:1/30/2019
Start Date:July 1, 2018
End Date:June 2024
Contact:TMTT Clinical
Email:TMTT_Clinical@edwards.com
Phone:949-250-2500

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Early feasibility study to assess the safety and performance of the Edwards Cardioband
Tricuspid Valve Reconstruction System

The study is a multi-center, prospective, single-arm, and non-randomized study designed to
evaluate the safety and performance of the Edwards Cardioband Tricuspid Valve Reconstruction
System

Inclusion Criteria:

- Chronic functional tricuspid regurgitation (moderate or greater)

- Symptomatic despite medical therapy

- The local site Heart Team determines that the patient is appropriate for transcatheter
tricuspid reconstruction

Exclusion Criteria:

- Unsuitable anatomy

- Primary tricuspid valve disease

- Previous tricuspid valve repair or replacement

- Co-morbid condition(s) that, in the opinion of the investigator, could limit the
patient's ability to participate in the study, including compliance with follow-up
requirements, or that could impact the scientific integrity of the study
We found this trial at
7
sites
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New York, NY
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1215 Lee St
Charlottesville, Virginia 22903
(434) 924-0211
Principal Investigator: Scott Lim, MD
Phone: 434-982-1058
University of Virginia Health System UVA Health System includes a 604-bed hospital, level I trauma...
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Charlottesville, VA
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303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: Charles Davidson, MD
Phone: 312-694-0661
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from
Chicago, IL
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Morristown, New Jersey 07962
Principal Investigator: Robert Kipperman, MD
Phone: 973-971-7541
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from
Morristown, NJ
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Plano, Texas 75093
Principal Investigator: Robert Smith, MD
Phone: 469-814-4737
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from
Plano, TX
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Rochester, Minnesota 55905
Principal Investigator: Mackram Eleid, MD
Phone: 507-255-9524
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from
Rochester, MN
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Wynnewood, Pennsylvania 19096
Principal Investigator: William Gray, MD
Phone: 484-476-8514
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from
Wynnewood, PA
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