Risk Stratification in Severe Treatment-naive, Tricuspid Regurgitation

• Conditions: Functional Tricuspid Regurgitation

• Registration Number: NCT04173091
• Lead Sponsor: Charite University, Berlin, Germany

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 available

Study Timeline

• Study Start: 2013-01-01
• Primary Completion: 2017-12-31
• Study First Submitted: 2019-11-16
• Study First Submitted QC: 2019-11-20
• Study First Posted: 2019-11-21
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-26
• Last Update Posted: 2020-03-27
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

Severe functional tricuspid regurgitation

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All-cause mortality	10 years	Mortality due to all causes

Secondary Outcome Measures

Name	Time	Method
Cardiovascular mortality	10 years	Mortality due to cardiovascular causes
Number of hospitalizations	10 years	Number of hospitalizations due to right heart failure

Trial Locations

Locations (5)

Brunilda Alushi; 🇩🇪 Berlin, Germany

Contilia Heart and Vascular Centre; 🇩🇪 Essen, Germany

Department of Internal Medicine and Cardiology, Heart Centre Leipzig; 🇩🇪 Leipzig, Germany

German Heart Centre; 🇩🇪 Munich, Germany

Rabin Medical Centre; 🇮🇱 Tel Aviv, Petah Tikva, Israel