The RESHAPE-HF1-FU Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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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).

Conditions
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Mitral Valve Insufficiency

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| standard care group<br>optimal standard of care therapy | |
| device group<br>Follow-up of MitraClip device implantation plus optimal standard of care therapy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiovascular (CV) death | Composite rate of recurrent heart failure hospitalizations and cardiovascular (CV) death | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mitral Regurgitation (MR) severity reduction | Mitral Regurgitation (MR) severity reduction to mild or mild-to-moderate at 12 and 24 months | at 12 and 24 months | 
| 6 Minute Walk Test (6MWT) | Change in 6 Minute Walk Test (6MWT) distance at 6, 12 and 24 months over baseline | at 6, 12 and 24 months | 
| CV hospitalizations and CV death | Rate of recurrent CV hospitalizations and CV death | 24 months | 
| Quality of Life (QoL) | Change in Quality of Life (QoL) overall score, as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) at 12 months over baseline | 12 months | 
| New York Heart Association (NYHA) Functional Class | 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, 12 and 24 months | 
| Patient-reported Global Assessment (PGA) | Change in Patient-reported Global Assessment (PGA) of well-being at 6, 12 and 24 months | 6, 12 and 24 months. |