NCT02444286

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2017

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 14, 2015

Completed
1.6 years until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

January 5, 2024

Status Verified

January 1, 2019

Enrollment Period

1 year

First QC Date

May 12, 2015

Last Update Submit

January 2, 2024

Conditions

Mitral Valve Insufficiency

Outcome Measures

Primary Outcomes (1)

  • cardiovascular (CV) death

    Composite rate of recurrent heart failure hospitalizations and cardiovascular (CV) death

    24 months

Secondary Outcomes (6)

  • Mitral Regurgitation (MR) severity reduction

    at 12 and 24 months

  • 6 Minute Walk Test (6MWT)

    at 6, 12 and 24 months

  • CV hospitalizations and CV death

    24 months

  • Quality of Life (QoL)

    12 months

  • New York Heart Association (NYHA) Functional Class

    6, 12 and 24 months

  • +1 more secondary outcomes

Study Arms (2)

standard care group

optimal standard of care therapy

device group

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • 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

You may not qualify if:

  • Withdrawal of Informed Consent
  • Subject belongs to a vulnerable population

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Medical Center Goettingen

Göttingen, 37075, Germany

Location

University Hospital Mainz

Mainz, 55131, Germany

Location

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2015

First Posted

May 14, 2015

Study Start

January 1, 2017

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

January 5, 2024

Record last verified: 2019-01

Locations

DE(2)