The RESHAPE-HF1-FU Study

Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH

Overview

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.

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 Type

OBSERVATIONAL

Conditions

Mitral Valve Insufficiency

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

University Medical Center Goettingen

Göttingen, Germany

University Hospital Mainz

Mainz, Germany

Outcomes

Primary Outcomes

cardiovascular (CV) death

Composite rate of recurrent heart failure hospitalizations and cardiovascular (CV) death

Time frame: 24 months

Secondary Outcomes

Mitral Regurgitation (MR) severity reduction

Mitral Regurgitation (MR) severity reduction to mild or mild-to-moderate at 12 and 24 months

Time frame: 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

Time frame: at 6, 12 and 24 months

CV hospitalizations and CV death

Rate of recurrent CV hospitalizations and CV death

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 6, 12 and 24 months.

Data from ClinicalTrials.gov

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