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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03745313
Recruitment Status : Recruiting
First Posted : November 19, 2018
Last Update Posted : January 31, 2020
Information provided by (Responsible Party):
Edwards Lifesciences

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

Condition or disease Intervention/treatment Phase
Tricuspid Regurgitation Device: Transcatheter Tricuspid Valve Repair Not Applicable

Detailed Description:
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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Edwards PASCAL TrAnScatheter Valve RePair System in Tricuspid Regurgitation (CLASP TR) Early Feasibility Study
Actual Study Start Date : February 5, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : December 31, 2025

Arm Intervention/treatment
Experimental: Treatment
Treatment with the Edwards PASCAL Transcatheter Valve Repair System
Device: Transcatheter Tricuspid Valve Repair
Repair of the tricuspid valve through a transcatheter approach
Other Name: Edwards PASCAL Transcatheter Valve Repair System

Primary Outcome Measures :
  1. Freedom from device or procedure-related adverse events [ Time Frame: 30 days ]
    Safety assessed by freedom from device or procedure-related adverse events

Secondary Outcome Measures :
  1. NYHA Functional Class [ Time Frame: 30 days, 6 Months, 12 Months, annual for five years ]
    Number of patients with improvement in NYHA class

  2. Six minute walk test [ Time Frame: 30 days , 6 months, 1 year ]
    Change in distance (m) from baseline

  3. Reduction in TR grade [ Time Frame: 30 days, 3 Months ,6 Months, 12 Months, annual for five years ]
    Number of patients with reduction in TR from baseline

  4. Health Status - KCCQ [ Time Frame: 30 days, 6 months, 1 year ]
    Number of points of improvement in health status as measured by Kansas City Cardiomyopathy Questionnaire

  5. Health Status - SF-36 [ Time Frame: 30 days, 6 months, 1 year ]
    Number of points of improvement in health status as measured by 36 item short form survey (SF-36)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03745313

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Contact: TMTT Clinical Affairs +1 (949) 250-2500

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United States, California
Cedars Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Mitch Gheorghiu    310-423-6410   
Contact: Navjot Sekhon    310-423-6410   
Principal Investigator: Raj Makkar, MD         
Sub-Investigator: Mamoo Nakamura, MD         
Sub-Investigator: Sabah Skaf, MD         
Sub-Investigator: Wen Cheng, MD         
Sub-Investigator: Siddarth Singh, MD         
Sub-Investigator: Moody Makar, MD         
Sub-Investigator: Luke Oakley, MD         
United States, Georgia
Emory University Hospital Recruiting
Atlanta, Georgia, United States, 30322
Contact: Elizabeth Charles    404-686-1249   
Contact: Kristy Pitts    404-685-5775   
Principal Investigator: Adam Greenbaum, MD         
Sub-Investigator: Vasilis Babaliaros, MD         
Sub-Investigator: Kendra Grubb, MD         
Sub-Investigator: Patrick Gleason, MD         
Sub-Investigator: Chandan Deveriddy, MD         
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Lyndsay Christensen    312-694-0661   
Contact: Elizabeth McCloskey    312-926-0840   
Principal Investigator: Charles Davidson, MD         
Sub-Investigator: Mark Ricciardi, MD         
Sub-Investigator: Akhil Narang, MD         
Sub-Investigator: Allen Anderson, MD         
Sub-Investigator: Chris Malaisrie, MD         
United States, Indiana
St. Vincent Heart Center of Indiana Recruiting
Indianapolis, Indiana, United States, 46290
Contact: Barbara Kingma    317-583-6319   
Contact: Mary Burkert    317-583-6116   
Principal Investigator: James Hermiller, MD         
Sub-Investigator: David Heimansohn, MD         
Sub-Investigator: Andrew Sampson, MD         
Sub-Investigator: Lucas Mitchel, MD         
Sub-Investigator: Sina Moainie, MD         
Sub-Investigator: Emily Wandel, PA         
United States, Michigan
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Ardit Kacorri    313-816-7452   
Contact: Ashish Solanki    313-816-3571   
Principal Investigator: William O'Neill, MD         
Sub-Investigator: Marvin Eng, MD         
Sub-Investigator: Tiberio Frisoli, MD         
Sub-Investigator: Dee Dee Wang, MD         
Sub-Investigator: Dimitrios Apostolou, MD         
Sub-Investigator: James Lee, MD         
Sub-Investigator: Pedro Villablanca, MD         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55902
Contact: Amanda Biddle    507-255-6133   
Contact: Craig Konwinski    507-255-6133   
Principal Investigator: Mackram Eleid, MD         
Sub-Investigator: Mayra Guerrero, MD         
Sub-Investigator: Grace Lin, MD         
Sub-Investigator: Sorin Pislaru, MD         
Sub-Investigator: Sunil Mankad, MD         
Sub-Investigator: John Stulak, MD         
Sub-Investigator: Chet Rihal, MD         
United States, New Jersey
Morristown Medical Center Recruiting
Morristown, New Jersey, United States, 07960
Contact: Christine Ciprich, RN    973-971-5951   
Contact: Catherine Van Zile, RN    973-971-5951   
Principal Investigator: Robert Kipperman, MD         
Sub-Investigator: Philippe Genereux, MD         
Sub-Investigator: John Brown, MD         
Sub-Investigator: Chris Magovern, MD         
Sub-Investigator: James Slater, MD         
Sub-Investigator: Leo Marcoff, MD         
Sub-Investigator: Konstantinos Koulogiannis, MD         
Sub-Investigator: Marc Goldschmidt, MD         
United States, New York
NYU Langone Health Recruiting
New York, New York, United States, 10016
Contact: Samantha Vidal    201-654-1976   
Contact: Illya Pushkar    212-263-4188   
Principal Investigator: Mathew Williams, MD         
Sub-Investigator: Cezar Staniloae, MD         
Sub-Investigator: Alan Vainrib, MD         
Sub-Investigator: Daniel Bamira, MD         
Sub-Investigator: Shaline Rao, MD         
Sub-Investigator: Hasan Jilaihawi, MD         
Sub-Investigator: Homam Ibrahim, MD         
Columbia University Medical Center/New York Presbyterian Hospital Recruiting
New York, New York, United States, 10032
Contact: Kate Dalton    347-514-3366   
Contact: Eriq Pettway    212-305-7060   
Principal Investigator: Susheel K Kodali, MD         
Sub-Investigator: Maritn B Leon, MD         
Sub-Investigator: Rebecca Hahn, MD         
Sub-Investigator: Omar Khalique, MD         
United States, Oregon
Oregon Health & Science University Active, not recruiting
Portland, Oregon, United States, 97239
United States, Pennsylvania
Lankenau Medical Center Recruiting
Wynnewood, Pennsylvania, United States, 19096
Contact: Jennifer Jordan, RN    484-476-8580   
Contact: Sherry McDermott    484-476-8580   
Principal Investigator: William Gray, MD         
Sub-Investigator: Scott Goldman, MD         
Sub-Investigator: Katie Hawthorne, MD         
Sub-Investigator: Sandra Abramson, MD         
Sub-Investigator: Steven Domsky, MD         
Sub-Investigator: Paul Coady, MD         
Sub-Investigator: Roberto Rodriguez, MD         
Sub-Investigator: Eric Gnall, MD         
Sub-Investigator: Christopher Droogan, MD         
United States, Texas
The Heart Hospital Baylor Plano Recruiting
Plano, Texas, United States, 75093
Contact: Necole Kell    469-814-4871   
Contact: Gabriella Velder    469-814-4720   
Principal Investigator: Robert Smith, MD         
Sub-Investigator: Molly Szerlip, MD         
Sub-Investigator: Timothy George, MD         
Sub-Investigator: Paul Grayburn, MD         
Sub-Investigator: Kelley Hutcheson, MD         
Sub-Investigator: Sameh Sayfo, MD         
United States, Virginia
University of Virginia Health System Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Linda Bailes-Bryceland    434-982-1058   
Contact: Jessica Morris    434-982-1058   
Principal Investigator: Scott Lim, MD         
Sub-Investigator: Gorav Ailawadi, MD         
Sub-Investigator: Sula Mazimba, MD         
Sponsors and Collaborators
Edwards Lifesciences
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Principal Investigator: Susheel K. Kodali, MD Columbia University
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Responsible Party: Edwards Lifesciences Identifier: NCT03745313    
Other Study ID Numbers: 2018-10
First Posted: November 19, 2018    Key Record Dates
Last Update Posted: January 31, 2020
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Edwards Lifesciences:
Additional relevant MeSH terms:
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Tricuspid Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases