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Trial record 4 of 4 for:    Transcatheter repair CLASP

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.
 
ClinicalTrials.gov Identifier: NCT04097145
Recruitment Status : Recruiting
First Posted : September 20, 2019
Last Update Posted : January 21, 2020
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

Brief Summary:
To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Tricuspid 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



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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:

  • 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 ClinicalTrials.gov identifier (NCT number): NCT04097145


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

Locations
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United States, New Jersey
Morristown Medical Center Recruiting
Morristown, New Jersey, United States, 07962
Contact: Christine Ciprich    973-971-5951    christine.ciprich@atlantichealth.org   
Contact: Diane Agar    973-971-5951    diane.agar@atlantichealth.org   
Principal Investigator: Robert Kipperman, MD         
Sub-Investigator: Philippe Genereux, MD         
Sub-Investigator: Marc Goldschmidt, MD         
Sub-Investigator: Konstantinos Koulogiannis, MD         
Sub-Investigator: Leo Marcoff, MD         
Sub-Investigator: John Brown, MD         
Sub-Investigator: James Slater, MD         
Sub-Investigator: Chris Magovern, MD         
United States, New York
Lenox Hill Hospital, Northwell Health Recruiting
New York, New York, United States, 10075
Contact: Amelia Ng, RN    212-434-4916    Ang13@northwell.edu   
Contact: Effe Mihelis    212-434-6614    emihelis@northwell.edu   
Principal Investigator: Chad Kliger, MD         
Sub-Investigator: Nirav C Patel, MD         
Sub-Investigator: Luigi Pirelli, MD         
Sub-Investigator: Priti Mehla, MD         
Sub-Investigator: Gerin Stevens, MD         
Sub-Investigator: Biana Trost, MD         
Sub-Investigator: Craig Basman, MD         
Sub-Investigator: Marick Kukin, MD         
Sub-Investigator: S. Jacob Scheinerman, MD         
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Kelsey Cameron    503-418-9677    cameronk@ohsu.edu   
Contact: Zoe Kilmer    503-494-3491    kilmer@ohsu.edu   
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         
Sponsors and Collaborators
Edwards Lifesciences

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Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT04097145    
Other Study ID Numbers: 2019-07
First Posted: September 20, 2019    Key Record Dates
Last Update Posted: January 21, 2020
Last Verified: January 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