The RESHAPE-HF1-FU Study

January 2, 2024 updated by: Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH

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).

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.

Study Overview

Status

Withdrawn

Conditions

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 Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Göttingen, Germany, 37075
        • University Medical Center Goettingen
      • Mainz, Germany, 55131
        • University Hospital Mainz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The RESHAPE- HF1-FU Study is an observational, multi-center clinical evaluation (follow-up) of the MitraClip device plus optimal standard of care therapy (subjects with Device) compared to optimal standard of care therapy alone (other subjects), of former participants in the RESHAPE-HF Trial (Abbott Vascular).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
standard care group
optimal standard of care therapy
device group
Follow-up of MitraClip device implantation plus optimal standard of care therapy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH

Collaborators

University Medical Center Goettingen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2017

Primary Completion (Estimated)

January 1, 2018

Study Completion (Estimated)

January 1, 2018

Study Registration Dates

First Submitted

May 12, 2015

First Submitted That Met QC Criteria

May 13, 2015

First Posted (Estimated)

May 14, 2015

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

January 2, 2024

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Version No. 1.0

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Mitral Valve Insufficiency

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Taiwan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe