NCT04173091

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.

Trial Health

47
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Geographic Reach
2 countries

5 active sites

Status
unknown

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

Study Start

First participant enrolled

January 1, 2013

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 16, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 21, 2019

Completed
4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

March 27, 2020

Status Verified

March 1, 2020

Enrollment Period

5 years

First QC Date

November 16, 2019

Last Update Submit

March 26, 2020

Conditions

Functional Tricuspid Regurgitation

Keywords

tricuspid regurgitation, tricuspid valve, percutaneous treatment, right ventricle

Outcome Measures

Primary Outcomes (3)

  • 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 (7)

  • Cardiovascular mortality

    1 year

  • Cardiovascular mortality

    5 years

  • Cardiovascular mortality

    10 years

  • Number of hospitalizations

    1 year

  • Number of hospitalizations

    2 years

  • +2 more secondary outcomes

Interventions

No InterventionDIAGNOSTIC_TEST

No Intervention planed

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with severe functional tricuspid regurgitation diagnosed echocardiographically.

You may qualify if:

  • Severe functional tricuspid regurgitation

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Brunilda Alushi

Berlin, 12200, Germany

RECRUITING

Contilia Heart and Vascular Centre

Essen, Germany

ACTIVE NOT RECRUITING

Department of Internal Medicine and Cardiology, Heart Centre Leipzig

Leipzig, Germany

RECRUITING

German Heart Centre

Munich, Germany

RECRUITING

Rabin Medical Centre

Tel Aviv, Petah Tikva, 49100, Israel

RECRUITING

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Head of Cardiac catheterization Laboratory

Study Record Dates

First Submitted

November 16, 2019

First Posted

November 21, 2019

Study Start

January 1, 2013

Primary Completion

December 31, 2017

Study Completion

December 30, 2023

Last Updated

March 27, 2020

Record last verified: 2020-03

Locations

DE(4)IL(1)