NCT02853955

Brief Summary

Percutaneous edge-to-edge repair of the mitral valve has been shown to be a safe and effective alternative treatment option for selected patients at high risk for cardiac surgery. Patients with recurrent mitral regurgitation after surgical mitral valve repair (sMVR) are per se at increased risk for another cardiac surgery. The purpose of this multicenter retrospective analysis of patients treated with a MitraClip® after sMVR, is to evaluate the effectiveness and durability of this minimally invasive treatment option in this subset of patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

March 31, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 3, 2016

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

September 1, 2016

Status Verified

July 1, 2016

Enrollment Period

4 months

First QC Date

March 31, 2016

Last Update Submit

August 31, 2016

Conditions

Mitral Regurgitation

Outcome Measures

Primary Outcomes (2)

  • Survival

    1 year

  • MR (mitral regurgitation) grade after clip treatment

    Scale 0-4

    1 year

Secondary Outcomes (10)

  • MR (mitral regurgitation) grade at latest follow up

    1 year

  • NYHA status at latest follow up

    1 year

  • Distance in 6 minute walk test at latest follow up

    1 year

  • LVEF (left ventricular ejection fraction) at latest follow up

    1 year

  • LVEDV (left ventricular enddiastolic volume) at latest follow up

    1 year

  • +5 more secondary outcomes

Interventions

Percutaneous edge-to-edge repair of the mitral valveDEVICE

MitraClip in patients with recurrent MI after surgical mitral valve repair.

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients treated with a MitraClip® after sMVR

You may qualify if:

  • All patients with recurrent mitral regurgitation treated with a MitraClip®.

You may not qualify if:

  • Patient with endocarditis,
  • Patients with torn mitral valve ring.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Munich University Hospital

Munich, Bavaria, 81377, Germany

RECRUITING

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Study Officials

  • Jörg Hausleiter, MD

    LMU Munich

    STUDY CHAIR

Central Study Contacts

Daniel Braun, MD

CONTACT

+49 89 4400Daniel.Braun@med.uni-muenchen.de

Jörg Hausleiter, MD

CONTACT

+49 89 4400Joerg.Hausleiter@med.uni-muenchen.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 31, 2016

First Posted

August 3, 2016

Study Start

May 1, 2016

Primary Completion

September 1, 2016

Study Completion

November 1, 2016

Last Updated

September 1, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)