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The CLASP Study Edwards PASCAL TrAnScatheter Mitral Valve RePair System Study (CLASP)

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ClinicalTrials.gov Identifier: NCT03170349
Recruitment Status : Recruiting
First Posted : May 31, 2017
Last Update Posted : April 8, 2019
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

Brief Summary:
The purpose of this study is to assess the safety, performance and clinical outcomes of the Edwards PASCAL Transcatheter Mitral Valve Repair (TMVr) System.

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

Detailed Description:
The purpose of this study is to assess the safety, performance and clinical outcomes of the Edwards PASCAL Transcatheter Mitral Valve Repair (TMVr) System. This is a multi-center, multi-national, prospective, single arm, safety, performance and clinical outcomes study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 245 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The CLASP Study Edwards PASCAL TrAnScatheter Mitral Valve RePair System Study
Actual Study Start Date : June 27, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : January 2024

Arm Intervention/treatment
Experimental: Edwards PASCAL Transcatheter Mitral Valve Repair System Device: Mitral Valve Repair
Minimal Invasive Transcatheter Mitral Valve Repair




Primary Outcome Measures :
  1. Composite of major adverse events (MAE) defined as cardiovascular mortality, stroke, myocardial infarction, new need for renal replacement therapy, severe bleeding and re-intervention for study device related complications at 30 days. [ Time Frame: The primary endpoint will be assessed at 30 days. ]

Secondary Outcome Measures :
  1. Mitral regurgitation reduction [ Time Frame: 30 days, 6 months, 1 year ]
  2. All-cause mortality [ Time Frame: 30 days , 6 months, 1 year ]
  3. Recurrent heart failure hospitalization [ Time Frame: 30 days , 6 months, 1 year ]
  4. Change in Six Minute Walk Test (6MWT) distance [ Time Frame: 6 months and 1 year ]


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:

  • Signed and dated IRB/ethics committee approved study consent form prior to study related procedures
  • Eighteen (18) years of age or older
  • New York Heart Association (NYHA) Functional Class II-IVa heart failure despite optimal medical therapy
  • Candidacy for surgical mitral valve repair or replacement determined by Heart Team evaluation
  • Clinically significant mitral regurgitation (moderate-to-severe or severe mitral regurgitation) confirmed by transesophageal echocardiography (TEE) and transthoracic echocardiography (TTE).
  • The primary regurgitant jet is non-commissural. If a secondary jet exists, it must be considered clinically insignificant.
  • Mitral valve area (MVA) ≥ 4.0 cm² as measured by planimetry. If MVA by planimetry is not measurable, pressure half-time measurement is acceptable.

Exclusion Criteria:

  • Patient in whom a TEE is contraindicated or screening TEE is unsuccessful
  • Leaflet anatomy which may preclude PASCAL device implantation, proper device positioning on the leaflets, or sufficient reduction in mitral regurgitation.
  • Mitral valve area (MVA) < 4.0 cm² as measured by planimetry (If MVA by planimetry is not measurable, PHT measurement is acceptable)
  • Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
  • Physical evidence of right sided congestive heart failure and echocardiographic evidence of severe right ventricular dysfunction
  • Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the Investigator
  • Patient is currently participating or has participated in another investigational drug or device clinical study where the primary study endpoint was not reached at time of enrollment
  • Patient is under guardianship

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): NCT03170349


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

Locations
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United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Mane Arabyan    310-248-8515    mane.arabyan@cshs.org   
Contact: Kelly Salazar    (310) 967-4375    kelly.salazar@cshs.org   
Principal Investigator: Raj Makkar, MD         
Sub-Investigator: Alfredo Trento, MD         
Sub-Investigator: Danny Ramzy, MD         
Sub-Investigator: Siddharth Singh, MD         
United States, Colorado
University of Colorado Denver Active, not recruiting
Aurora, Colorado, United States, 80045
United States, Illinois
NorthShore University HealthSystem Active, not recruiting
Evanston, Illinois, United States, 60201
United States, Michigan
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Ashley Hill    313-916-7430    ahill13@hfhs.org   
Contact: Farah Jarjous    313 916-4475    fjarjou1@hfhs.org   
Principal Investigator: William O'Neill, MD         
Sub-Investigator: Marvin H Eng, MD         
Sub-Investigator: Dee Dee Wang, MD         
Sub-Investigator: James Lee, MD         
Sub-Investigator: Hassan Nemeh, MD         
Sub-Investigator: Raed M Alnajjar, MD         
United States, New Jersey
Morristown Medical Center Recruiting
Morristown, New Jersey, United States, 07960
Contact: Catherine Van Zile    973-971-4099    Catherine.vanzile@atlantichealth.org   
Contact: Christine Ciprich    973-971-7541    christine.ciprich@atlantichealth.org   
Principal Investigator: Robert Kipperman, MD         
Sub-Investigator: John Brown, MD         
Sub-Investigator: Philippe Genereux, MD         
Sub-Investigator: Konstantinos Koulogiannis, MD         
Sub-Investigator: Leo Marcoff, MD         
United States, North Carolina
Carolinas Medical Center Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Sally Aberle, RN    704-355-4794    Sally.Aberle@carolinashealthcare.org   
Contact: Susan McClain, RN    704-355-4794    Susan.Mcclain@carolinashealthcare.org   
Principal Investigator: Michael Rinaldi, MD         
United States, Texas
The Heart Hospital Baylor Plano Recruiting
Plano, Texas, United States, 75093
Contact: Brittany ZIngler    469-814-4737    Brittany.Zingler@bswhealth.org   
Contact: Necole Kell    469-814-4871      
Principal Investigator: Robert L Smith, MD         
United States, Virginia
University of Virginia Health System Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Linda Bailes, RN, CCRC    434-982-1058    Lgs2m@virginia.edu   
Contact: Jessica Morris    434-982-1058    JLM6UW@virginia.edu   
Principal Investigator: D. Scott Lim, MD         
Australia, Chermside
Metro North Hospital & Health Service, The Prince Charles Hospital Active, not recruiting
Brisbane, Chermside, Australia, QLD 4032
Australia, New South Wales
Sydney Local Health District, Royal Prince Alfred Hospital Active, not recruiting
Camperdown, New South Wales, Australia, 2050
Canada, British Columbia
St. Paul's Hospital, Providence Health Care Research Institute Active, not recruiting
Vancouver, British Columbia, Canada, V6E 1M7
Canada, Ontario
Sunnybrook Hospital Completed
Toronto, Ontario, Canada, M4N 3M5
St Michael Hospital Active, not recruiting
Toronto, Ontario, Canada, M5B-1W8
Germany
Universitaetsklinikum Bonn, Medizinische Klinik II, Kardiologie Active, not recruiting
Bonn, Germany, 53127
Greece
Hygeia Hospital Active, not recruiting
Athens, Greece, 15123
Italy
San Rafaelle Hospital Active, not recruiting
Milano, Italy, 20132
Switzerland
Inselspital, University Hospital Bern Active, not recruiting
Bern, Switzerland, 3010
Sponsors and Collaborators
Edwards Lifesciences
Investigators
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Principal Investigator: Gideon Cohen, MD Sunnybrook Hospital
Principal Investigator: Ulrich Schafer, MD University Medical Center Hamburg
Principal Investigator: Molly Szerlip, MD The Heart Hospital Baylor

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Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT03170349     History of Changes
Other Study ID Numbers: 2016-05
First Posted: May 31, 2017    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases