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Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial (CLASP IID/IIF)

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ClinicalTrials.gov Identifier: NCT03706833
Recruitment Status : Recruiting
First Posted : October 16, 2018
Last Update Posted : December 1, 2021
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

Tracking Information
First Submitted Date  ICMJE October 10, 2018
First Posted Date  ICMJE October 16, 2018
Last Update Posted Date December 1, 2021
Actual Study Start Date  ICMJE November 30, 2018
Estimated Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 26, 2021)
  • PASCAL is not inferior to MitraClip with respect to the proportion of patients with major adverse events (MAE). The primary safety endpoint is a composite of Major Adverse Events (MAEs). [ Time Frame: 30 days. ]
  • PASCAL is not inferior to Mitraclip with respect to the proportion of patients with MR severity reduction as measured by echocardiography using a scale of 0-4+ for the CLASP IID Cohort. [ Time Frame: 6 months ]
  • PASCAL is not inferior to Mitraclip with respect to the time to first heart failure hospitalization or death for the CLASP IIF Cohort only. [ Time Frame: From date of randomization until date of first heart failure hospitalization or death, through 5 year follow-up ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 26, 2021)
  • Rates of various adverse events [ Time Frame: 6 months; 12 months ]
    Rates of various adverse events at 6 and 12 months
  • Functional Improvement (increase in 6 minute walk test in meters) [ Time Frame: 30 days , 6 months, 1 year ]
    Increase in 6 minute walk test in meters
  • Functional improvement (quality of life) as assessed using the Kansas City Cardiomyopathy Questionnaire through 2 years [ Time Frame: 30 days , 6 months, 1 year, 2 year ]
    Number of points of improvement on a scale of 0-100 in Kansas City Cardiomyopathy Questionnaire, with higher scores associated with higher Quality of Life
  • Functional improvement (quality of life) as assessed by number of points of improvement on the Short Form Health Survey (SF-36) questionnaire through 2 years [ Time Frame: 30 days, 6 months, 1 year, 2 year ]
    Number of points of improvement on a scale of 0-100 in Short Form Health Survey (SF-36) questionnaire, with higher totals associated with higher Quality of Life
  • Functional improvement (quality of life) as assessed by number of points of improvement on the Short Form Health Survey (EQ-5D-5L) questionnaire through [ Time Frame: 30 days, 6 months, 1 year, 2 year ]
    Number of points of improvement on a scale of 1-100 in Short Form Health Survey (EQ-5D-5L) questionnaire, with higher totals associated with higher Quality of Life
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial
Official Title  ICMJE Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial (CLASP IID/IIF): A Prospective, Multicenter, Randomized, Controlled Pivotal Trial to Evaluate the Safety and Effectiveness of Transcatheter Mitral Valve Repair With the Edwards PASCAL Transcatheter Valve Repair System Compared to Abbott MitraClip in Patients With Mitral Regurgitation
Brief Summary To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System in patients with degenerative mitral regurgitation (DMR) who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team, and in patients with functional mitral regurgitation (FMR) on guideline directed medical therapy (GDMT)
Detailed Description

A prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter mitral valve repair with the Edwards PASCAL Transcatheter Valve Repair System compared to Abbott MitraClip in patients with degenerative mitral regurgitation (DMR) who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team, and in patients with functional mitral regurgitation (FMR) on guideline directed medical therapy (GDMT)

Patients will be seen for follow-up visits at discharge, 30 days, 6 months, and annually through 5 years.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Degenerative Mitral Valve Disease
  • Mitral Regurgitation
  • Mitral Insufficiency
  • Functional Mitral Regurgitation
Intervention  ICMJE
  • Device: Edwards PASCAL System
    Transcatheter mitral valve repair with the Edwards PASCAL System
    Other Name: Transcatheter Mitral Valve repair (TMVr)
  • Device: Abbott Mitraclip System
    Transcatheter mitral valve repair with the Abbott Mitraclip System
    Other Name: Transcatheter Mitral Valve repair (TMVr)
Study Arms  ICMJE
  • Experimental: Edwards PASCAL System - CLASP IID
    Transcatheter mitral valve repair with the Edwards PASCAL System in patients with degenerative mitral regurgitation
    Intervention: Device: Edwards PASCAL System
  • Active Comparator: Abbott Mitraclip System - CLASP IID
    Transcatheter mitral valve repair with the Abbott Mitraclip System in patients with degenerative mitral regurgitation
    Intervention: Device: Abbott Mitraclip System
  • Experimental: Edwards PASCAL System - CLASP IIF
    Transcatheter mitral valve repair with the Edwards PASCAL System in patients on guideline directed medical therapy with functional mitral regurgitation
    Intervention: Device: Edwards PASCAL System
  • Active Comparator: Abbott Mitraclip System - CLASP IIF
    Transcatheter mitral valve repair with the Abbott Mitraclip System in patients on guideline directed medical therapy with functional mitral regurgitation
    Intervention: Device: Abbott Mitraclip System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 21, 2019)
1275
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date  ICMJE January 31, 2028
Estimated Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Eighteen (18) years of age or older
  • Patient is able and willing to give informed consent and follow protocol procedures, and comply with follow-up visit requirements.
  • Patient is determined to be at prohibitive risk for mitral valve surgery by the heart team (CLASP IID cohort only).
  • Patient is on stable heart failure medications/Guideline Directed Medical Therapy (CLASP IIF cohort only)
  • Patient is determined to be a candidate for transcatheter mitral valve repair by the heart team for both PASCAL and MitraClip
  • Mitral regurgitation (3+ to 4+) by echo
  • Suitable valve and regurgitant jet morphology
  • Elevated BNP > 150 pg/ml or corrected NT-pro BNP of > 600 pg/ml or heart failure hospitalization within the past 12 months (CLASP IIF cohort only)

Exclusion Criteria:

  • Patient in whom a TEE is contraindicated or screening TEE is unsuccessful
  • Mitral valve anatomy which may preclude proper PASCAL or MitraClip access, use and/or deployment or sufficient reduction in mitral regurgitation
  • Patient with refractory heart failure requiring advanced intervention (i.e. left ventricular assist device, transplantation) (ACC/AHA Stage D heart failure)
  • 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
  • Any prior mitral valve surgery or transcatheter mitral valve procedure (excluding chordal replacement or surgical annuloplasty repair)
  • Active rheumatic heart disease or rheumatic etiology for MR
  • Severe aortic stenosis or regurgitation
  • Known history of untreated, severe carotid stenosis
  • History of deep vein thrombosis (DVT) or pulmonary embolism (PE)
  • Severe COPD
  • Pregnant or planning pregnancy within 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Edwards TMTT Clinical Affairs (949) 250-2500 TMTT_Clinical@edwards.com
Listed Location Countries  ICMJE Canada,   Germany,   Switzerland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03706833
Other Study ID Numbers  ICMJE 2018-07
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Edwards Lifesciences
Study Sponsor  ICMJE Edwards Lifesciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Scott Lim, MD University of Virginia
Principal Investigator: Robert Smith, MD The Heart Hospital Baylor Plano
Principal Investigator: Linda Gillam, MD Morristown Medical Center
Principal Investigator: Vinod Thourani, MD Piedmont Healthcare
Principal Investigator: Paul Grayburn, MD The Heart Hospital Baylor Plano
Principal Investigator: Brian K Whisenant, MD Intermountain Medical Center
Principal Investigator: Jörg Hausleiter, MD LMU München, Campus Gorsshadern
Principal Investigator: Ralph Stephan von Bardeleben, MD / Universitätsmedizin Mainz- Zentrum für Kardiologie
PRS Account Edwards Lifesciences
Verification Date November 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP