The RESHAPE-HF1-FU Study

Institut für anwendungsorientierte Forschung und klinische Studien

Status: Withdrawn

Conditions: Mitral Valve Insufficiency

Study type: Observational

Funder types: Other

Identifiers

NCT02444286

Version No. 1.0

Details and patient eligibility

About

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.

Full 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).

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 2 patient groups

standard care group

Description:

optimal standard of care therapy

device group

Description:

Follow-up of MitraClip device implantation plus optimal standard of care therapy