Valvular Heart Disease Registry | NCT03488732

Studies
Valvular Heart Disease Registry

NCT03488732

Sponsor

Technical University of Munich

Status

Recruiting

Last Update Posted

Apr 10, 2019Actual

Enrollment

2,000Estimated

Phase

Not provided

Conditions

Valvular Heart Disease

Interventions

Transcatheter valvular repair or replacement

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

Apr 2019

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

Apr 1, 2015Actual

Primary Completion Date

Jan 1, 2025Estimated

Completion Date

Jan 1, 2030Estimated

First Submitted Date

Mar 27, 2018

First Submission Date that Met QC Criteria

Apr 4, 2018

First Posted Date

Apr 5, 2018Actual

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

Apr 9, 2019

Last Update Posted Date

Apr 10, 2019Actual

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

Patients undergoing transcatheter valvular interventions will be prospectively included into the present registry. Baseline, procedural and follow-up data will be collected and analyzed to adress various issues in the field of percutaneous valvular interventions.

Detailed Description

Not provided

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

10 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients undergonig transcatheter valvular interventions			Device: Transcatheter valvular repair or replacement

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Transcatheter valvular repair or replacement	Device	Transcatheter valvular repair (predominantly MitraClip for mitral regurgitation) or replacement (predominantly transcatheter aortic valve implantation for aortic stenosis)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
All-cause mortality		10 years

Secondary Outcomes

Measure	Description	Time Frame
Cardiovascular mortality		10 years
NYHA status		10 years
Grade of mitral regurgitation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- Severe valvular defect planned for valvular intervention

Exclusion Criteria:

- No informed consent

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing transcatheter valvular interventions

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Klinik für Innere Medizin I	Recruiting	München			Germany

Condition Browse Module

MeSH Terms

ID	Term
D006349	Heart Valve Diseases

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D012092	Replantation

Ancestor Terms

ID	Term
D014180	Transplantation
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided