NCT02444286
Withdrawn
Not Applicable
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).
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH2 sites in 1 countryJanuary 2017
ConditionsMitral Valve Insufficiency
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mitral Valve Insufficiency
- Sponsor
- Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
- Locations
- 2
- Primary Endpoint
- cardiovascular (CV) death
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
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.
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).
Investigators
Eligibility 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
Outcomes
Primary Outcomes
cardiovascular (CV) death
Time Frame: 24 months
Composite rate of recurrent heart failure hospitalizations and cardiovascular (CV) death
Secondary Outcomes
- 6 Minute Walk Test (6MWT)(at 6, 12 and 24 months)
- CV hospitalizations and CV death(24 months)
- Patient-reported Global Assessment (PGA)(6, 12 and 24 months.)
- Mitral Regurgitation (MR) severity reduction(at 12 and 24 months)
- Quality of Life (QoL)(12 months)
- New York Heart Association (NYHA) Functional Class(6, 12 and 24 months)
Study Sites (2)
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