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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06307262
Other study ID # EuroTR Registry
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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