The RESHAPE-HF1-FU Study

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).

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02444286

Enrollment

Registered

2015-05-14

Start date

2017-01-31

Completion date

2018-01-31

Last updated

2024-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mitral Valve Insufficiency

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
cardiovascular (CV) death	24 months	Composite rate of recurrent heart failure hospitalizations and cardiovascular (CV) death

Secondary

Measure	Time frame	Description
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
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
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
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
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

Countries

Germany

Outcome results