The Prospecive OBSERVational Munich Interventional MITRAl... | NCT04577248

Studies
The Prospecive OBSERVational Munich Interventional MITRAl-Valve Registry

NCT04577248

Sponsor

Deutsches Herzzentrum Muenchen

Status

Recruiting

Last Update Posted

Oct 8, 2020Actual

Enrollment

5,000Estimated

Phase

Not provided

Conditions

Mitral Valve Regurgitation
Mitral Valve Stenosis
Tricuspid Valve Regurgitation

Interventions

edge-to-edge valve repair

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

Oct 2020

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 15, 2020Actual

Primary Completion Date

Dec 31, 2030Estimated

Completion Date

Jan 1, 2031Estimated

First Submitted Date

Oct 1, 2020

First Submission Date that Met QC Criteria

Oct 1, 2020

First Posted Date

Oct 6, 2020Actual

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

Oct 6, 2020

Last Update Posted Date

Oct 8, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

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

Prospective, single-center observational registry including all consecutive patients treated with transcatheter mitral or tricuspid valve therapy at the Deutsches Herzzentrum München, Germany.

Detailed Description

Long-term mortality after transcatheter mitral or tricuspid valve therapy

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

5,000Estimated

Name	Type	Description	Arm Group Labels	Other Names
edge-to-edge valve repair	Device	edge-to-edge valve repair

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Long-term mortality	Long-term mortality	5 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age above 18 years and consentable
Mitral Valve Regurgitation, Mitral Valve Stenosis, Tricuspid Valve Regurgitation, Tricuspid Stenosis
Transcatheter mitral or tricuspid valve therapy considered best option by heart-team decision
Written informed consent

Exclusion Criteria:

Patient's inability to fully cooperate with the protocol

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

110 Years

Standard Ages

AdultOlder Adult

Study Population

All-comers patient population treated with transcatheter mitral or tricuspid valve therapy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Patrick Mayr, MD	Contact	+498912180		mayrp@dhm.mhn.de
Joner Michael, Prof	Contact	+498912180		joner@dhm.mhn.de

Overall Officials

Name	Affiliation	Role
Patrick Mayr, MD	Dept. of Anesthesiology, Deutsches Herzzentrum München	Study Chair
Michael Joner, Prof	Dept. of Cardiology, Deutsches Herzzentrum München	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Deutsches Herzzentrum München des Freistaates Bayern, Technische Universität München	Recruiting	Munich	Bavaria	D80636	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
D008946	Mitral Valve Stenosis
D014262	Tricuspid Valve Insufficiency

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided