The RESHAPE-HF1-FU Study

NCT ID: NCT02444286

Last Updated: 2024-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-31

Study Completion Date

2018-01-31

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).

Conditions

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Mitral Valve Insufficiency

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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standard care group

optimal standard of care therapy

No interventions assigned to this group

device group

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

No interventions assigned to this group

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Medical Center Goettingen

OTHER

Sponsor Role collaborator

Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Medical Center Goettingen

Göttingen, , Germany

Site Status

University Hospital Mainz

Mainz, , Germany

Site Status

Countries

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Germany

Other Identifiers

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Version No. 1.0

Identifier Type: -

Identifier Source: org_study_id

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