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Trial record 1 of 1 for:    NCT03706833
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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 : August 1, 2019
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

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)

Condition or disease Intervention/treatment Phase
Degenerative Mitral Valve Disease Mitral Regurgitation Mitral Insufficiency Functional Mitral Regurgitation Device: Edwards PASCAL System Device: Abbott Mitraclip System Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1275 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 30, 2018
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : January 31, 2028

Arm Intervention/treatment
Experimental: Edwards PASCAL System - CLASP IID
Transcatheter mitral valve repair with the Edwards PASCAL System in patients with degenerative mitral regurgitation
Device: Edwards PASCAL System
Transcatheter mitral valve repair with the Edwards PASCAL System
Other Name: Transcatheter Mitral Valve repair (TMVr)

Active Comparator: Abbott Mitraclip System - CLASP IID
Transcatheter mitral valve repair with the Abbott Mitraclip System in patients with degenerative mitral regurgitation
Device: Abbott Mitraclip System
Transcatheter mitral valve repair with the Abbott Mitraclip System
Other Name: Transcatheter Mitral Valve repair (TMVr)

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
Device: Edwards PASCAL System
Transcatheter mitral valve repair with the Edwards PASCAL System
Other Name: Transcatheter Mitral Valve repair (TMVr)

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
Device: Abbott Mitraclip System
Transcatheter mitral valve repair with the Abbott Mitraclip System
Other Name: Transcatheter Mitral Valve repair (TMVr)




Primary Outcome Measures :
  1. 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. ]
  2. 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+. [ Time Frame: 6 months ]
  3. PASCAL is not inferior to MitraClip with respect to the proportion of patients with recurrent heart failure hospitalizations and all-cause mortality [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Rates of various adverse events [ Time Frame: 6 months; 12 months ]
    Rates of various adverse events at 6 and 12 months

  2. 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

  3. Functional improvement (quality of life) as assessed using the Kansas City Cardiomyopathy Questionnaire [ Time Frame: 30 days , 6 months, 1 year ]
    Number of points of improvement in Kansas City Cardiomyopathy Questionnaire

  4. Functional improvement (quality of life) as assessed by number of points of improvement on the Short Form Health Survey (SF-36) questionnaire [ Time Frame: 30 days, 6 months, 1 year ]
    Number of points of improvement in Short Form Health Survey (SF-36) questionnaire



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:

  • 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. biventricular pacemakers, 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 (except surgical annuloplasty) or transcatheter mitral valve procedure
  • Active rheumatic heart disease or rheumatic etiology for MR
  • Severe aortic stenosis or regurgitation
  • Known history of severe symptomatic 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

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): NCT03706833


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

  Show 31 Study Locations
Sponsors and Collaborators
Edwards Lifesciences
Investigators
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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: Jeff Popma, MD Beth Israel Deaconess Medical Center
Principal Investigator: Vinod Thourani, MD Medstar Washington Hospital Center
Principal Investigator: Paul Grayburn, MD The Heart Hospital Baylor Plano

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Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT03706833     History of Changes
Other Study ID Numbers: 2018-07
First Posted: October 16, 2018    Key Record Dates
Last Update Posted: August 1, 2019
Last Verified: July 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
Pediatric Postmarket Surveillance of a Device Product: No

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