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The RESHAPE-HF1-FU Study

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ClinicalTrials.gov Identifier: NCT02444286
Recruitment Status : Withdrawn (study did never start, may be deleted from clinicaltrials.gov if possible)
First Posted : May 14, 2015
Last Update Posted : January 10, 2019
Sponsor:
Collaborator:
University Medical Center Goettingen, sponsor of the study
Information provided by (Responsible Party):
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH

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

Condition or disease
Mitral Valve Insufficiency

Detailed Description:
The purpose of the RESHAPE-HF1-FU Study is to follow up the safety and effectiveness of the MitraClip System in the treatment of clinically significant Functional Mitral Regurgitation (FMR) in patients with New York Heart Association (NYHA) Functional Class III or IV chronic heart failure, former participants in the RESHAPE-HF Trial (Abbott Vascular).
Study Design
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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study of Heart Failure Patients With Clinically Significant Functional Mitral Regurgitation - Follow Up of the Former Participants in the RESHAPE-HF Trial (Abbott Vascular).
Study Start Date : January 2017
Estimated Primary Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Groups and Cohorts
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Group/Cohort
standard care group
optimal standard of care therapy
device group
Follow-up of MitraClip device implantation plus optimal standard of care therapy


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. 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) [ 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: 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: 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
Sampling Method:   Non-Probability Sample
Study Population
The RESHAPE- HF1-FU Study is an observational, multi-center clinical evaluation (follow-up) of the MitraClip device plus optimal standard of care therapy (subjects with Device) compared to optimal standard of care therapy alone (other subjects), of former participants in the RESHAPE-HF Trial (Abbott Vascular).
Criteria

Inclusion Criteria:

  • Former participant in the RESHAPE-HF Trial (Abbott Vascular)
  • Subject agrees to return for all required follow-up visits
  • The subject has been informed of the nature of the study and agrees to the study's provisions and has provided written informed consent as approved by the respective clinical site's Ethics Committee

Exclusion Criteria:

  • Withdrawal of Informed Consent
  • Subject belongs to a vulnerable population
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): NCT02444286


Locations
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Germany
University Medical Center Goettingen
Goettingen, Germany, 37075
University Hospital Mainz
Mainz, Germany, 55131
Sponsors and Collaborators
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
University Medical Center Goettingen, sponsor of the study
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
ClinicalTrials.gov Identifier: NCT02444286    
Other Study ID Numbers: Version No. 1.0
First Posted: May 14, 2015    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
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Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases