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A Clinical Evaluation of the Safety and Effectiveness of the MitraClip System in the Treatment of Clinically Significant Functional Mitral Regurgitation (Reshape-HF2)

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: NCT02444338
Recruitment Status : Recruiting
First Posted : May 14, 2015
Last Update Posted : January 13, 2020
Sponsor:
Collaborator:
University Medical Center Goettingen
Information provided by (Responsible Party):
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH

Study Description
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Brief Summary:
To study the safety and effectiveness of the MitraClip System in the treatment of clinically significant functional mitral regurgitation in patients with New York Heart Association (NYHA) Functional Class II to Class IV chronic heart failure.

Condition or disease Intervention/treatment Phase
Mitral Valve Insufficiency Device: MitraClip Other: standard of care Not Applicable

Detailed Description:
The trial is designed to provide additional evidence regarding appropriate recommendations for use of the MitraClip System for patients with chronic heart failure and clinically significant functional mitral regurgitation. Additionally, the trial will collect evidence regarding health economics of the MitraClip System for use in this patient population.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A RandomizEd Study of tHe MitrACliP DEvice in Heart Failure Patients With Clinically Significant Functional Mitral Regurgitation
Study Start Date : March 2015
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Control Group
optimal standard of care therapy
 Other: standard of care
Experimental: Device Group
MitraClip device plus optimal standard of care therapy
 Device: MitraClip
Implantation of the MitraClip System for patients with chronic heart failure.

Other: standard of care


Outcome Measures
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Primary Outcome Measures :
  1. cardiovascular (CV) death [ Time Frame: 24 months ]
    Composite rate of recurrent heart failure hospitalizations and cardiovascular (CV) death


Secondary Outcome Measures :
  1. Mitral Regurgitation (MR) severity reduction [ Time Frame: at 12 and 24 months ]
    Mitral Regurgitation (MR) severity reduction to mild or mild-to-moderate at 12 and 24 months;

  2. Change in 6 Minute Walk Test (6MWT) [ Time Frame: at 6, 12 and 24 months ]
    Change in 6 Minute Walk Test (6MWT) distance at 6, 12 and 24 months over baseline;

  3. CV hospitalizations and CV death [ Time Frame: 24 months ]
    Rate of recurrent CV hospitalizations and CV death

  4. Quality of Life (QoL) overall score [ Time Frame: 12 months ]
    Change in Quality of Life (QoL) overall score, as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) at 12 months over baseline

  5. New York Heart Association (NYHA) Functional Class [ Time Frame: at 6, 12 and 24 months ]
    Change in New York Heart Association (NYHA) Functional Class over baseline and proportions of patients in NYHA Functional Class I/II at 6, 12 and 24 months

  6. Patient-reported Global Assessment (PGA) [ Time Frame: at 6, 12 and 24 months ]
    Change in Patient-reported Global Assessment (PGA) of well-being at 6, 12 and 24 months


Eligibility Criteria
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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

Key Inclusion Criteria:

  • Clinically significant functional mitral regurgitation (moderate-to-severe or severe MR) as defined by European Association of Echocardiography, within 90 days prior to randomization and confirmed by the Echocardiography Core Laboratory Note: The TTE must be obtained after the subject has been stabilized on optimal therapy and has undergone revascularization and/or CRT, as appropriate
  • Assessed by the investigator to be on optimal standard of care therapy for heart failure, according to current ESC/HFA guidelines with no dose changes of heart failure drugs (with the exception of diuretics) during the last 2 weeks immediately prior to randomization.
  • Symptomatic with documented New York Heart Association Class II, III or IV heart failure, despite optimal standard of care therapy, within 30 days preceding randomization
  • Minimum of one documented hospitalization (acute care admission or emergency room visit) for heart failure within 12 months preceding randomization OR values of 300 pg/mL for BNP or 1000 pg/mL for NT-proBNP after optimal medical and/or device management within 90 days preceding randomization Note: BNP or NT-proBNP must be obtained after the subject has been stabilized on optimal therapy and has undergone revascularization and/or CRT, as appropriate
  • Left ventricular ejection fraction (LVEF) of ≥ 15% to ≤ 35% (if in NYHA Functional Class II) or of ≥ 15% to ≤ 45% (if in NYHA Functional Class III or IV).

Note: LVEF needs to be determined by one of the following methods: transthoracic echocardiography (TTE), contrast ventriculography, gated blood pool scan, cardiac magnetic resonance) within 90 days prior to randomization

- Patient is ambulatory and able to perform a 6MWT with the only limiting factor(s) being due to cardiovascular fitness

Key Exclusion Criteria:

  • Mitral regurgitation is primarily due to degenerative disease of the mitral valve apparatus (Degenerative MR) as determined by transesophageal echocardiography (TEE).
  • Status 1 heart transplant or prior orthotropic heart transplantation.
  • Introduction of a new heart failure drug class within the last 2 weeks prior to randomization.
  • Evidence of acute coronary syndrome, transient ischemic attack or stroke within 90 days prior to randomization.
  • Any percutaneous cardiovascular intervention, carotid surgery, cardiovascular surgery, or atrial fibrillation ablation within 90 days prior to randomization.
  • Therapy with or without cardioverter-defibrillator (CRT or CRT-D), or Implantable Cardioverter Defibrillator (ICD)) within 90 day prior to randomization, or revision of any implanted rhythm management device within 90 days prior to randomization.
  • Need for any cardiovascular surgery.
  • Mitral valve surgery is considered the preferred therapeutic option for the subject
  • Renal replacement therapy
  • 6-Minute Walk Test (6MWT) distance > 475 meters
  • Mitral Valve Area (MVA) by planimetry < 4.0 cm2; if MVA by planimetry is not measurable, pressure half-time measurement is acceptable; MVA must be confirmed by the Echocardiography Core Laboratory
Contacts and Locations
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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): NCT02444338


Contacts
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Contact: Stefan Anker, Prof. (+)49 30 450 553 151 s.anker@cachexia.de
Contact: Wolfgang Schillinger, Prof. (+49)5551/97-12 44 medizinischeklinik.northeim@helios-kliniken.de

Locations
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Sponsors and Collaborators
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
University Medical Center Goettingen
More Information
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Responsible Party: Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
ClinicalTrials.gov Identifier: NCT02444338    
Other Study ID Numbers: Version No. 3.4
First Posted: May 14, 2015    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020
Additional relevant MeSH terms:
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Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases