The RESHAPE-HF1-FU Study

Withdrawn

• Conditions: Mitral Valve Insufficiency

• Registration Number: NCT02444286
• Lead Sponsor: Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH

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).

Study Timeline

• Study First Submitted: 2015-05-12
• Study First Submitted QC: 2015-05-13
• Study First Posted: 2015-05-14
• Study Start: 2017-01
• Primary Completion: 2018-01
• Study Completion: 2018-01
• Status Verified: 2019-01
• Last Update Submitted: 2024-01-02
• Last Update Posted: 2024-01-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
cardiovascular (CV) death	24 months	Composite rate of recurrent heart failure hospitalizations and cardiovascular (CV) death

Secondary Outcome Measures

Name	Time	Method
6 Minute Walk Test (6MWT)	at 6, 12 and 24 months	Change in 6 Minute Walk Test (6MWT) distance at 6, 12 and 24 months over baseline
CV hospitalizations and CV death	24 months	Rate of recurrent CV hospitalizations and CV death
Patient-reported Global Assessment (PGA)	6, 12 and 24 months.	Change in Patient-reported Global Assessment (PGA) of well-being at 6, 12 and 24 months
Mitral Regurgitation (MR) severity reduction	at 12 and 24 months	Mitral Regurgitation (MR) severity reduction to mild or mild-to-moderate at 12 and 24 months
Quality of Life (QoL)	12 months	Change in Quality of Life (QoL) overall score, as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) at 12 months over baseline
New York Heart Association (NYHA) Functional Class	6, 12 and 24 months	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

Trial Locations

Locations (2)

University Medical Center Goettingen; 🇩🇪 Göttingen, Germany

University Hospital Mainz; 🇩🇪 Mainz, Germany