The RESHAPE-HF1-FU Study

Mitral Valve Insufficiency Clinical Trial

Official title:

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).

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02444286
• Other study ID #: Version No. 1.0
• Status: Withdrawn
• Start date: January 2017
• Est. completion date: January 2018

Study information

• Verified date: January 2019
• Source: Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mitral Valve Insufficiency

Locations

Country	Name	City	State
Germany	University Medical Center Goettingen	Göttingen
Germany	University Hospital Mainz	Mainz

Sponsors (2)

Lead Sponsor	Collaborator
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH	University Medical Center Goettingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cardiovascular (CV) death	Composite rate of recurrent heart failure hospitalizations and cardiovascular (CV) death	24 months
Secondary	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
Secondary	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
Secondary	CV hospitalizations and CV death	Rate of recurrent CV hospitalizations and CV death	24 months
Secondary	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
Secondary	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
Secondary	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.