NCT01502462

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
131

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 29, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 30, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
8.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

February 2, 2021

Status Verified

February 1, 2021

Enrollment Period

8.9 years

First QC Date

December 29, 2011

Last Update Submit

February 1, 2021

Conditions

Tricuspid Regurgitation

Keywords

Clinical course and prognostic factors in patients with severe isolated TR

Outcome Measures

Primary Outcomes (1)

  • all cause death

    5 years

Secondary Outcomes (3)

  • Hospitalization of cardiovascular causes

    5 years

  • tricuspid valve surgery

    5 years

  • stroke

    5 years

Eligibility Criteria

Age16 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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

You may qualify if:

  • Severe isolated TR for more than 6 months

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

Location

MeSH Terms

Conditions

Tricuspid Valve InsufficiencyDisease Progression

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

December 29, 2011

First Posted

December 30, 2011

Study Start

February 1, 2012

Primary Completion

December 30, 2020

Study Completion

December 30, 2020

Last Updated

February 2, 2021

Record last verified: 2021-02

Locations

KR(1)