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Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial (CLASP II TR)

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: NCT04097145
Recruitment Status : Recruiting
First Posted : September 20, 2019
Last Update Posted : August 12, 2020
Information provided by (Responsible Party):
Edwards Lifesciences

Brief Summary:
To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Repair System in patients with symptomatic severe tricuspid regurgitation who have been determined to be at an intermediate or greater estimated risk of mortality with tricuspid valve surgery by the cardiac surgeon with concurrence by the local Heart Team

Condition or disease Intervention/treatment Phase
Tricuspid Regurgitation Tricuspid Valve Insufficiency Tricuspid Valve Disease Device: Edwards PASCAL System Drug: Optimal Medical Therapy Not Applicable

Detailed Description:
A Prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter tricuspid valve repair with the Edwards PASCAL Transcatheter Valve Repair System and optimal medical therapy (OMT) compared to OMT alone in patients with tricuspid regurgitation. Patients will be seen for follow-up visits at discharge, 30 days, 3 months, 6 months, and annually through 5 years.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 825 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter, Randomized, Controlled Pivotal Trial to Evaluate the Safety and Effectiveness of Transcatheter Tricuspid Valve Repair With the Edwards PASCAL Transcatheter Valve Repair System and Optimal Medical Therapy (OMT) Compared to OMT Alone in Patients With Tricuspid Regurgitation
Actual Study Start Date : December 11, 2019
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : March 2027

Arm Intervention/treatment
Experimental: Edwards PASCAL System & OMT
Transcatheter tricuspid valve repair with the Edwards PASCAL system in patients on optimal medical therapy (OMT) with tricuspid regurgitation
Device: Edwards PASCAL System
Transcatheter tricuspid valve repair with the Edwards PASCAL System in patients on optimal medical therapy
Other Name: Transcatheter tricuspid valve repair (TTVr)

Active Comparator: Optimal Medical Therapy (OMT)
Optimal medical therapy (OMT) alone in patients with tricuspid regurgitation
Drug: Optimal Medical Therapy
Optimal Medical Therapy alone in patients with tricuspid regurgitation

Primary Outcome Measures :
  1. Hierarchical composite endpoint of various adverse events and improvement in quality of life [ Time Frame: 24 months ]
    Comparison of a composite of adverse events including mortality, heart failure hospitalization, need for surgery on the tricuspid valve, and improvement of quality of life

Secondary Outcome Measures :
  1. Rates of various adverse events [ Time Frame: 30 days ]
    Rates of various adverse events at 30 days

  2. Reduction in TR grade [ Time Frame: 30 days, 3 months, 6 months, 12 months, annual for 5 years ]
    Number of patients with reduction in TR from baseline

  3. Health Status - KCCQ [ Time Frame: 30 days, 6 months, 1 year, 2 years ]
    Number of points of improvement in health status as measured by Kansas City Cardiomyopathy Questionnaire

  4. Health Status - SF-36 [ Time Frame: 30 days, 6 months, 1 year, 2 years ]
    Number of points of improvement in health status as measured by 36 item short form survey (SF-36)

  5. Six-Minute Walk Test [ Time Frame: 30 days, 6 months, 1 year, 2 years ]
    Change in distance (m) from baseline

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:

  • Eighteen (18) years of age or older
  • Patient is deemed symptomatic despite medical therapy and confirmed by the local Heart Team
  • Severe or greater tricuspid regurgitation
  • New York Heart Association (NYHA) Class II-IVa or heart failure hospitalization in the prior 12 months
  • Patient is at an intermediate or greater estimated risk of mortality with tricuspid valve surgery as determined by the cardiac surgeon with concurrence by the local Heart Team
  • Patient is able and willing to give informed consent, follow protocol procedures, and comply with follow-up visit requirements

Exclusion Criteria:

  • Tricuspid valve anatomy not evaluable by TTE and TEE
  • Tricuspid valve anatomy precludes proper device deployment and function
  • Patient with refractory heart failure requiring advanced intervention (i.e. left ventricular assist device, transplantation) (ACC/AHA Stage D heart failure)
  • Primary non-degenerative tricuspid disease
  • Previous tricuspid valve repair or replacement that would interfere with placement of PASCAL
  • Clinically significant, untreated coronary artery disease
  • Recent Stroke
  • Other severe valve disorders requiring intervention
  • Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months
  • Severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation
  • Active endocarditis
  • Continuous home oxygen for primary severe COPD
  • Pregnant or planning pregnancy within the next 12 months. Note: Female patients of childbearing potential need to have a negative pregnancy test performed within 14 days prior to intervention and be adherent to an accepted method of contraception
  • Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the Investigator
  • Patient is currently participating in another investigational biologic, drug or device clinical study where the primary study endpoint was not reached at time of enrollment
  • Other medical, social, or psychological conditions that preclude appropriate consent and follow-up, including patients 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 identifier (NCT number): NCT04097145

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Contact: Edwards TMTT Clinical Affairs (949) 250-2500

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United States, California
Stanford University Active, not recruiting
Stanford, California, United States, 94305
United States, Colorado
Medical Center of the Rockies Active, not recruiting
Loveland, Colorado, United States, 80538
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Elle McCloskey, RN    312-926-0840   
Contact: Christina Arroyo    312-926-7078   
Principal Investigator: Charles Davidson, MD         
Sub-Investigator: S. Chris Malaisrie, MD         
Sub-Investigator: Jyothy Puthumana, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Arpi Tavil-Shatelyan    617-726-2612   
Contact: Lina Fu, RN    617-643-1371   
Principal Investigator: Sammy Elmariah, MD         
Principal Investigator: Ignacio Inglessis, MD         
Sub-Investigator: Rahul Sakhuja, MD         
Sub-Investigator: Arminder Jassar, MD         
Sub-Investigator: Nathaniel Langer, MD         
Sub-Investigator: Serguei Melnitchouk, MD         
Sub-Investigator: Jacob Dal-Bianco, MD         
Sub-Investigator: Evin Yucel, MD         
Sub-Investigator: Igor Palacios, MD         
Sub-Investigator: Khue Ton, MD         
Sub-Investigator: William Carlson, MD         
Sub-Investigator: Matthew Nayor, MD         
Sub-Investigator: Erin Coglianese, MD         
Sub-Investigator: Ravi Shah, MD         
United States, Michigan
University of Michigan Active, not recruiting
Ann Arbor, Michigan, United States, 48109
Henry Ford Hospital Active, not recruiting
Detroit, Michigan, United States, 48202
United States, Minnesota
Mayo Clinic Active, not recruiting
Rochester, Minnesota, United States, 55905
United States, New Jersey
Morristown Medical Center Active, not recruiting
Morristown, New Jersey, United States, 07962
United States, New York
Lenox Hill Hospital, Northwell Health Active, not recruiting
New York, New York, United States, 10075
St. Francis Hospital Recruiting
Roslyn, New York, United States, 11576
Contact: Lyn Santiago, RN    516-562-6790   
Contact: Meghan Murray, RN    516-562-6790   
Principal Investigator: George A Petrossian, MD         
Principal Investigator: Newell B Robinson, MD         
Sub-Investigator: William Chung, MD         
Sub-Investigator: Rita Jermyn, MD         
Sub-Investigator: Lin Wang, MD         
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Kelsey Cameron    503-418-9677   
Contact: Zoe Kilmer    503-494-3491   
Principal Investigator: Firas Zahr, MD         
Principal Investigator: Scott Chadderdon, MD         
Sub-Investigator: Howard Song, MD         
Sub-Investigator: Johannes Steiner, MD         
Sub-Investigator: Katerine Rajotte         
Sub-Investigator: Stephanie Khouw         
United States, Pennsylvania
Pinnacle Health Cardiovascular Institute/UPMC Pinnacle Recruiting
Wormleysburg, Pennsylvania, United States, 17043
Contact: Courtney Rodgers    717-639-6410   
Contact: Dawn Mac Farlane, LPN    717-601-0300   
Principal Investigator: Mubashir Mumtaz, MD         
Principal Investigator: Hemal Gada, MD         
Sub-Investigator: Atizazul Mansoor, MD         
Sub-Investigator: Roberto Hodara, MD         
Sub-Investigator: Brian Corbally, DO         
Sub-Investigator: Amit Vora, MD         
Sub-Investigator: David Loran, MD         
United States, Tennessee
Vanderbilt University Medical Center Active, not recruiting
Nashville, Tennessee, United States, 37212
United States, Texas
HCA Houston Healthcare Medical Center Active, not recruiting
Houston, Texas, United States, 77004
The University of Texas Health Science Center at Houston Active, not recruiting
Houston, Texas, United States, 77030
Baylor Scott & White - The Heart Hospital - Plano Recruiting
Plano, Texas, United States, 75093
Contact: Gabriella Velder    469-814-4732   
Contact: Necole Kell    469-814-4871   
Principal Investigator: Robert L. Smith, MD         
Sub-Investigator: Molly Szerlip, MD         
Sub-Investigator: Paul Grayburn, MD         
Sub-Investigator: Karim Al-Azizi, MD         
Sub-Investigator: Sameh Sayfo, MD         
Sponsors and Collaborators
Edwards Lifesciences
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Responsible Party: Edwards Lifesciences Identifier: NCT04097145    
Other Study ID Numbers: 2019-07
First Posted: September 20, 2019    Key Record Dates
Last Update Posted: August 12, 2020
Last Verified: July 2020
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
Additional relevant MeSH terms:
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Tricuspid Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases