Prospective Registry of Patients With Isolated Severe Tri... | NCT01502462

Studies
Prospective Registry of Patients With Isolated Severe Tricuspid Regurgitation

NCT01502462

Sponsor

Asan Medical Center

Status

Completed

Last Update Posted

Feb 2, 2021Actual

Enrollment

131Actual

Phase

Not provided

Conditions

Tricuspid Regurgitation

Interventions

Not provided

Countries

South Korea

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

Feb 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2012Actual

Primary Completion Date

Dec 30, 2020Actual

Completion Date

Dec 30, 2020Actual

First Submitted Date

Dec 29, 2011

First Submission Date that Met QC Criteria

Dec 29, 2011

First Posted Date

Dec 30, 2011Estimated

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

Feb 1, 2021

Last Update Posted Date

Feb 2, 2021Actual

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

Prospective registry for patients with severe isolated tricuspid regurgitation (TR) without significant left-sided valvular or myocardial diseases.

Aim: To evaluate clinical course and prognostic factors of patients with severe isolated TR.

Detailed Description

Inclusion criteria Severe isolated TR for more than 6 months

Exclusion criteria

Severe mitral and aortic valvular heart disease
Age equals to or more than 75 years
Malignancy or serious comorbidity with life expectancy < 5years
Acute or subacute infective endocarditis requiring antibiotics therapy
Untreated hyperthyroidism
Constrictive pericarditis
Unclosed significant atrial septal defect
Previous tricuspid valve surgery
Significant coronary artery disease
Cardiomyopathy
Pregnancy
Severe resting pulmonary hypertension(TR Vmax >4.0 m/s)

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

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

131Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
all cause death		5 years

Secondary Outcomes

Measure	Description	Time Frame
Hospitalization of cardiovascular causes		5 years
tricuspid valve surgery		5 years
stroke

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria

Severe isolated TR for more than 6 months

Exclusion criteria

Severe mitral and aortic valvular heart disease
Age equals to or more than 75 years
Malignancy or serious comorbidity with life expectancy < 5years
Acute or subacute infective endocarditis requiring antibiotics therapy
Untreated hyperthyroidism
Constrictive pericarditis
Unclosed significant atrial septal defect
Previous tricuspid valve surgery
Significant coronary artery disease
Cardiomyopathy
Pregnancy
Severe resting pulmonary hypertension(TR Vmax >4.0 m/s)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

75 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Prospective registry for patients with severe isolated tricuspid regurgitation (TR) without significant left-sided valvular or myocardial diseases.

Aim: To evaluate clinical course and prognostic factors of patients with severe isolated TR

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Asan Medical Center		Seoul		138-736	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D014262	Tricuspid Valve Insufficiency
D018450	Disease Progression

Ancestor Terms

ID	Term
D006349	Heart Valve Diseases
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D020969	Disease Attributes

Browse Leaves

Not provided

Browse Branches

Not provided