European Registry of Transcatheter Repair for Tricuspid Regurgitation

Heart Failure Clinical Trial

— EuroTR  

Official title:

European Registry of Transcatheter Repair for Tricuspid Regurgitation (EuroTR)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06307262
• Other study ID #: EuroTR Registry
• Status: Recruiting
• Start date: October 23, 2023
• Est. completion date: December 31, 2030

Study information

• Verified date: March 2024
• Source: LMU Klinikum
• Contact: Jörg Hausleiter, Prof. Dr.
• Phone: +49 89 4400 72360
• Email: Joerg.Hausleiter[@]med.uni-muenchen.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

To investigate clinical and survival outcomes following transcatheter tricuspid valve repair or replacement.

Description:

Background and Rationale: Tricuspid regurgitation (TR) is a major health and economic burden due to high rates of heart failure hospitalizations, morbidity and mortality. Surcial treatment of TR is associated with high procedural and in-hospital mortality. Due to prohibitive surgical risk, a significant proportion of patients historically remained untreted beyond medical therapy. Transcatheter tricuspid valve (TV) repair and replacement techniques (TTVT) now offer a new treatment perspective for these patients. The EuroTR registry aims at optimizing patient selection prior to TTVT and thus treatment quality by collecting respective data in a real-world setting. Objectives: To investigate clinical and survival outcome following transcatheter tricuspid valve repair or replacement.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients treated with one of the following transcatheter devices for TV repair or replacement: PASCAL, TriClip, TricValve, Evoque, LuX-Valve
• Age = 18 years

Related Conditions & MeSH terms

• Heart Diseases
• Heart Failure
• Heart Valve Diseases
• Tricuspid Regurgitation
• Tricuspid Valve Insufficiency
• Valvular Heart Disease

Intervention

Device:
• T-TEER
T-TEER using the PACAL or TriClip device

Locations

Country	Name	City	State
Germany	LMU Klinikum	Munich	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
LMU Klinikum

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality		5 years
Secondary	Technical success	absence of procedural mortality, successful access, delivery and retrieval of the delivery system, successful deployment and positioning, freedom from emergency surgery	5 years
Secondary	Procedural Safety	periprocedural and in-hospital adverse events	5 years
Secondary	Heart Failure Biomarker	NT-proBNP level	5 years
Secondary	Dyspnea on exertion	New York Heart Association (NYHA) functional class	5 years
Secondary	Functional capacity	6-minute walk distance (6MWD)	5 years
Secondary	Right ventricular size	Mid-ventricular diameter of the right ventricle measured by echocardiography	5 years
Secondary	Right ventricular function	Right ventricular fractional area change measured by echocardiography	5 years
Secondary	Tricuspid regurgitation reduction	Tricuspid regurgitation severity measured by echocardiography	5 years
Secondary	Tricuspid valve stenosis	Transvalvular pressure gradient measured by echocardiography	5 years
Secondary	Pulmonary hypertension	Pulmonary artery pressure measured by echocardiography	5 years
Secondary	Right heart congestion	Inferior vena cava dimensions measured by echocardiography	5 years
Secondary	Hospitalization for heart failure	Date and number of heart failure hospitalizations after the index procedure	5 years