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Edwards CLASP TR EFS (CLASP TR EFS)

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.
 
ClinicalTrials.gov Identifier: NCT03745313
Recruitment Status : Recruiting
First Posted : November 19, 2018
Last Update Posted : June 2, 2020
Sponsor:
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

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

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 ClinicalTrials.gov identifier (NCT number): NCT03745313


Contacts
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Contact: TMTT Clinical Affairs +1 (949) 250-2500 TMTT_Clinical@edwards.com

Locations
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United States, California
Cedars Sinai Medical Center Active, not recruiting
Los Angeles, California, United States, 90048
United States, Georgia
Emory University Hospital Recruiting
Atlanta, Georgia, United States, 30322
Contact: Elizabeth Charles    404-686-1249    Elizabeth.z.charles@emory.edu   
Contact: Kristy Pitts    404-685-5775    klpitts@emory.edu   
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    Lyndsay.Christensen@nm.org   
Contact: Elizabeth McCloskey    312-926-0840    Elizabeth.McCloskey@nmg.org   
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    barbara.kingma@ascension.org   
Contact: Mary Burkert    317-583-6116    mary.burkert@ascension.org   
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 Active, not recruiting
Detroit, Michigan, United States, 48202
United States, Minnesota
Mayo Clinic Active, not recruiting
Rochester, Minnesota, United States, 55902
United States, New Jersey
Morristown Medical Center Active, not recruiting
Morristown, New Jersey, United States, 07960
United States, New York
NYU Langone Health Recruiting
New York, New York, United States, 10016
Contact: Samantha Vidal    201-654-1976    samantha.vidal@nyulangone.org   
Contact: Illya Pushkar    212-263-4188    illya.pushkar@nyulangone.org   
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 Active, not recruiting
New York, New York, United States, 10032
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Andrea Rohr    216-445-6821    rohra@ccf.org   
Contact: Rita Brienza    216-444-0122    brienzr@ccf.org   
Principal Investigator: Samir Kapadia, MD         
Sub-Investigator: Amar Krishnaswamy, MD         
Sub-Investigator: Grant Reed, MD         
Sub-Investigator: James Yun, MD         
Sub-Investigator: Serge Harb, MD         
Sub-Investigator: Rhonda Miyasaka, MD         
Sub-Investigator: Jerry Estep, MD         
United States, Oregon
Oregon Health & Science University Active, not recruiting
Portland, Oregon, United States, 97239
United States, Pennsylvania
Lankenau Medical Center Active, not recruiting
Wynnewood, Pennsylvania, United States, 19096
United States, Texas
The Heart Hospital Baylor Plano Active, not recruiting
Plano, Texas, United States, 75093
United States, Utah
Intermountain Medical Center Active, not recruiting
Murray, Utah, United States, 84107
United States, Virginia
University of Virginia Health System Active, not recruiting
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
Edwards Lifesciences
Investigators
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Principal Investigator: Susheel K. Kodali, MD Columbia University
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Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT03745313    
Other Study ID Numbers: 2018-10
First Posted: November 19, 2018    Key Record Dates
Last Update Posted: June 2, 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:
Functional
TR
FTR
Transcatheter
Repair
Regurgitation
Degenerative
Additional relevant MeSH terms:
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Tricuspid Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases