Edwards CLASP TR EFS



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:3/2/2019
Start Date:February 5, 2019
End Date:December 31, 2025
Contact:TMTT Clinical Affairs
Email:TMTT_Clinical@edwards.com
Phone:+1 (949) 250-2500

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Trial Summary
Trial Overview
Inclusion Criteria

Edwards PASCAL TrAnScatheter Valve RePair System in Tricuspid Regurgitation (CLASP TR) Early Feasibility Study

Early feasibility study to assess the safety and performance of the Edwards PASCAL
Transcatheter Valve Repair System in tricuspid regurgitation

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

Inclusion Criteria:

- Severe functional or degenerative TR

- Symptomatic despite medical therapy

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

Exclusion Criteria:

- Unsuitable anatomy

- 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
3
sites
Morristown Medical Center
Morristown, New Jersey 07962
Principal Investigator: Robert Kipperman, MD
Phone: 973-971-5951
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Morristown, NJ
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Northwestern University
303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: Charles Davidson, MD
Phone: 312-694-0661
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Chicago, IL
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Columbia University Medical Center and the New York Presbyterian Hospital
New York, New York 10032
Principal Investigator: Susheel K Kodali, MD
Phone: 347-514-3366
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New York, NY
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