MitraClip® After Surgical Mitral Valve Repair | NCT02853955

Studies
MitraClip® After Surgical Mitral Valve Repair

NCT02853955

Sponsor

LMU Klinikum

Status

Unknown status

Last Update Posted

Sep 1, 2016Estimated

Enrollment

30Estimated

Phase

Not provided

Conditions

Mitral Regurgitation

Interventions

Percutaneous edge-to-edge repair of the mitral valve

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2016

Primary Completion Date

Sep 2016Estimated

Completion Date

Nov 2016Estimated

First Submitted Date

Mar 31, 2016

First Submission Date that Met QC Criteria

Jul 29, 2016

First Posted Date

Aug 3, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 31, 2016

Last Update Posted Date

Sep 1, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

In this multicenter retrospective analysis of MitraClip® cases after MVR the effectiveness and durability of this minimally invasive treatment option in this subset of patients will be evaluated.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Percutaneous edge-to-edge repair of the mitral valve	Device	MitraClip in patients with recurrent MI after surgical mitral valve repair.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Survival		1 year
MR (mitral regurgitation) grade after clip treatment	Scale 0-4	1 year

Secondary Outcomes

Measure	Description	Time Frame
MR (mitral regurgitation) grade at latest follow up	Scale 0-4	1 year
NYHA status at latest follow up		1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Patient with endocarditis,
Patients with torn mitral valve ring.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

95 Years

Standard Ages

AdultOlder Adult

Study Population

patients treated with a MitraClip® after sMVR

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Daniel Braun, MD	Contact	+49 89 4400	73052	Daniel.Braun@med.uni-muenchen.de
Jörg Hausleiter, MD	Contact	+49 89 4400	72360	Joerg.Hausleiter@med.uni-muenchen.de

Overall Officials

Name	Affiliation	Role
Jörg Hausleiter, MD	LMU Munich	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Munich University Hospital	Recruiting	Munich	Bavaria	81377	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008944	Mitral Valve Insufficiency

Ancestor Terms

ID	Term
D006349	Heart Valve Diseases
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided