Risk Stratification in Severe Treatment-naive, Tricuspid... | NCT04173091

Studies
Risk Stratification in Severe Treatment-naive, Tricuspid Regurgitation

NCT04173091

Sponsor

Charite University, Berlin, Germany

Status

Unknown status

Last Update Posted

Mar 27, 2020Actual

Enrollment

2,000Estimated

Phase

Not provided

Conditions

Functional Tricuspid Regurgitation

Interventions

No Intervention

Countries

Germany
Israel

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

Mar 2020

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

Jan 1, 2013Actual

Primary Completion Date

Dec 31, 2017Actual

Completion Date

Dec 30, 2023Estimated

First Submitted Date

Nov 16, 2019

First Submission Date that Met QC Criteria

Nov 20, 2019

First Posted Date

Nov 21, 2019Actual

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

Mar 26, 2020

Last Update Posted Date

Mar 27, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Alexander Lauten, Professor, Head of Cardiac catheterization Laboratory, Charite University, Berlin, GermanyPrincipal Investigator

Lead Sponsor

Charite University, Berlin, GermanyOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

This registry is aimed to characterize patients with severe tricuspid regurgitation for the purpose of patient selection for interventional treatment and identify factors related to adverse outcomes.

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

Name	Type	Description	Arm Group Labels	Other Names
No Intervention	Diagnostic Test	No Intervention planed

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
All-cause mortality	Mortality due to all causes	1 year
All-cause mortality	Mortality due to all causes	5 years
All-cause mortality	Mortality due to all causes	10 years

Secondary Outcomes

Measure	Description	Time Frame
Cardiovascular mortality	Mortality due to cardiovascular causes	1 year
Cardiovascular mortality	Mortality due to cardiovascular causes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Severe functional tricuspid regurgitation

Exclusion Criteria:

prior surgery or congenital heart diseases with involvement of the tricuspid valve

Accepts Healthy Volunteers

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 with severe functional tricuspid regurgitation diagnosed echocardiographically.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Brunilda Alushi	Recruiting	Berlin		12200	Germany

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
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